Trial Outcomes & Findings for Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (NCT NCT01062399)
NCT ID: NCT01062399
Last Updated: 2022-06-09
Results Overview
DLT is defined as any of the following events occurring during the first 8 weeks of treatment with RAD001 and temozolomide and attributable to the study drugs: any grade 3 or 4 thrombocytopenia, grade 4 anemia, or grade 4 neutropenia lasting more than 7 days; any non-hematologic grade 3 or greater adverse event (AE), excluding alopecia, despite maximal medical therapy; any grade 4 radiation-induced skin changes; failure to recover from adverse events to be eligible for re-treatment with RAD001 and temozolomide within 14 days of the last dose of either drug; or any episode of non-infectious pneumonitis grade 2, 3, or 4 of any duration. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
279 participants
Primary outcome timeframe
From start of treatment to eight weeks.
Results posted on
2022-06-09
Participant Flow
A total of 279 patients registered at 1st registration for central pathology review of histology confirmation. Among 279 patients, 72 patients did not go beyond 2nd step registration due to insufficient tissue, patient refusal, progression of disease, and other reasons.
Participant milestones
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph II: RT + TMZ
Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
|
Ph II: RT + TMZ + RAD001
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
8
|
89
|
92
|
|
Overall Study
COMPLETED
|
8
|
9
|
8
|
83
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
6
|
4
|
Reasons for withdrawal
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph II: RT + TMZ
Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
|
Ph II: RT + TMZ + RAD001
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
6
|
4
|
Baseline Characteristics
Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
n=8 Participants
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
n=9 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
n=8 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph II: RT + TMZ
n=83 Participants
Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
|
Ph II: RT + TMZ + RAD001
n=88 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=93 Participants
|
57 years
n=4 Participants
|
57 years
n=27 Participants
|
57 years
n=483 Participants
|
61 years
n=36 Participants
|
59 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
80 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
56 Participants
n=36 Participants
|
116 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to eight weeks.Population: First 6 eligible phase I patients at each dose level who started study treatment
DLT is defined as any of the following events occurring during the first 8 weeks of treatment with RAD001 and temozolomide and attributable to the study drugs: any grade 3 or 4 thrombocytopenia, grade 4 anemia, or grade 4 neutropenia lasting more than 7 days; any non-hematologic grade 3 or greater adverse event (AE), excluding alopecia, despite maximal medical therapy; any grade 4 radiation-induced skin changes; failure to recover from adverse events to be eligible for re-treatment with RAD001 and temozolomide within 14 days of the last dose of either drug; or any episode of non-infectious pneumonitis grade 2, 3, or 4 of any duration. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE
Outcome measures
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
n=6 Participants
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
n=6 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
n=6 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|
|
Phase I: Number of Patients With Dose-limiting Toxicity (DLT)
|
2 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.Population: Eligible phase II patients
Using the Response Assessment in Neuro- Oncology (RANO) criteria, the progression 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. PFS time is defined as time from registration to date of progression, death, or last known follow-up (censored). PFS rates are estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
n=83 Participants
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
n=88 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|
|
Phase II: Progression-free Survival (PFS)
|
10.2 months
Interval 7.5 to 13.8
|
8.2 months
Interval 6.5 to 10.6
|
—
|
SECONDARY outcome
Timeframe: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.Population: Eligible phase II patients
Overall survival time is defined as time from/randomization to the 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.
Outcome measures
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
n=83 Participants
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
n=88 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|
|
Phase II: Overall Survival (OS)
|
21.2 months
Interval 16.6 to 29.9
|
16.5 months
Interval 12.5 to 18.7
|
—
|
SECONDARY outcome
Timeframe: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.Population: Eligible phase I patients who started the corresponding study treatment and had adverse events assessed.
AE reporting in Phase I was split up by treatment timing: concurrent treatment (RT, TMZ, RAD001); post-RT treatment (TMZ, RAD001) along with all AE's reported in follow-up. The worst/highest grade of any adverse event reported in each time period was determined for each patient. The percentage of patients in each grade level is reported. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
n=8 Participants
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
n=9 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
n=8 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|
|
Phase I: Distribution of Worst Adverse Event Grade
Concurrent treatment: Grade 1
|
0.0 percentage of participants
|
11.1 percentage of participants
|
12.5 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Concurrent treatment: Grade 2
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Concurrent treatment: Grade 3
|
50.0 percentage of participants
|
44.4 percentage of participants
|
87.5 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Concurrent treatment: Grade 4
|
50.0 percentage of participants
|
11.1 percentage of participants
|
0.0 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Concurrent treatment: Grade 5
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Post-RT treatment: Grade 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Post-RT treatment: Grade 2
|
0.0 percentage of participants
|
42.9 percentage of participants
|
100.0 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Post-RT treatment: Grade 3
|
71.4 percentage of participants
|
28.6 percentage of participants
|
0.0 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Post-RT treatment: Grade 4
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Phase I: Distribution of Worst Adverse Event Grade
Post-RT treatment: Grade 5
|
14.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.Population: Eligible phase II patients who started study treatment and had adverse events assessed.
The worst/highest grade of any adverse event reported was determined for each patient. The percentage of patients in each grade level is reported. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
n=77 Participants
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
n=85 Participants
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|
|
Phase II: Distribution of Worst Adverse Event Grade
Grade 1
|
0 percentage of patients
|
0 percentage of patients
|
—
|
|
Phase II: Distribution of Worst Adverse Event Grade
Grade 2
|
0 percentage of patients
|
3 percentage of patients
|
—
|
|
Phase II: Distribution of Worst Adverse Event Grade
Grade 3
|
3 percentage of patients
|
5 percentage of patients
|
—
|
|
Phase II: Distribution of Worst Adverse Event Grade
Grade 4
|
3 percentage of patients
|
0 percentage of patients
|
—
|
|
Phase II: Distribution of Worst Adverse Event Grade
Grade 5
|
2 percentage of patients
|
1 percentage of patients
|
—
|
Adverse Events
Ph I: RT + TMZ + RAD001 2.5 mg/Day
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Ph I: RT + TMZ + RAD001 5 mg/Day
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Ph I: RT + TMZ + RAD001 10 mg/Day
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Ph II: RT + TMZ
Serious events: 17 serious events
Other events: 76 other events
Deaths: 0 deaths
Ph II: RT + TMZ + RAD001
Serious events: 49 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
n=8 participants at risk
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
n=9 participants at risk
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
n=8 participants at risk
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph II: RT + TMZ
n=77 participants at risk
Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
|
Ph II: RT + TMZ + RAD001
n=85 participants at risk
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Chest pain - cardiac
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Ileus
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Death NOS
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema limbs
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Facial pain
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.1%
6/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Gait disturbance
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Cranial nerve infection
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Duodenal infection
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Meningitis
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Creatinine increased
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
INR increased
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphocyte count decreased
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.8%
10/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
5/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.9%
11/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight loss
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
White blood cell decreased
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.4%
8/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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)
Myelodysplastic syndrome
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Central nervous system necrosis
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysarthria
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysphasia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Seizure
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.9%
3/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.6%
9/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Confusion
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Suicidal ideation
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thromboembolic event
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.8%
10/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Ph I: RT + TMZ + RAD001 2.5 mg/Day
n=8 participants at risk
Radiation therapy (RT), concurrent temozolomide (TMZ), and concurrent RAD001 2.5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 5 mg/Day
n=9 participants at risk
Radiation therapy, concurrent temozolomide, and concurrent RAD001 5 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph I: RT + TMZ + RAD001 10 mg/Day
n=8 participants at risk
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
Ph II: RT + TMZ
n=77 participants at risk
Radiation therapy and concurrent temozolomide followed by post-radiation temozolomide
|
Ph II: RT + TMZ + RAD001
n=85 participants at risk
Radiation therapy, concurrent temozolomide, and concurrent RAD001 10 mg/day followed by post-radiation temozolomide and post-radiation RAD001 10 mg/day
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
31.2%
24/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
62.4%
53/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
5/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
5/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.4%
8/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.8%
10/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Endocrine disorders
Cushingoid
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Blurred vision
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.7%
9/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.3%
13/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Dry eye
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Optic nerve disorder
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colitis
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
49.4%
38/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
42.4%
36/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.9%
13/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.8%
16/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.9%
3/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.2%
7/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Mucositis oral
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.8%
6/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.6%
32/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
55.6%
5/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
62.5%
5/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
54.5%
42/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
56.5%
48/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.5%
15/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.9%
22/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema limbs
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.0%
10/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.8%
16/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
100.0%
8/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
87.5%
7/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
87.0%
67/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
80.0%
68/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fever
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.6%
9/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Gait disturbance
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
5/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Irritability
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Immune system disorders
Allergic reaction
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Bladder infection
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Enterocolitis infectious
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Mucosal infection
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.1%
6/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
32.5%
25/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
31.8%
27/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
36.4%
28/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
48.2%
41/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
62.5%
5/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
62.5%
5/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
24.7%
19/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.7%
38/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.7%
9/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.8%
10/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
CD4 lymphocytes decreased
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
11/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.4%
8/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Cholesterol high
|
100.0%
8/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
66.7%
6/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
100.0%
8/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
27.3%
21/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
65.9%
56/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Creatinine increased
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.8%
6/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
17/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
INR increased
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Investigations - Other
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.8%
6/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.1%
12/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphocyte count decreased
|
87.5%
7/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
77.8%
7/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
100.0%
8/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
55.8%
43/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.6%
49/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
24.7%
19/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
31.8%
27/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
87.5%
7/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
48.1%
37/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
64.7%
55/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight loss
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.2%
18/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
White blood cell decreased
|
62.5%
5/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
87.5%
7/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
46.8%
36/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
52.9%
45/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
5/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
44.4%
4/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
32.5%
25/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
40.0%
34/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.9%
3/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
5/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
87.5%
7/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
39.0%
30/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
51.8%
44/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.4%
8/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.1%
6/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
66.7%
6/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.2%
14/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
62.4%
53/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
62.5%
5/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
17/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.6%
12/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
27.1%
23/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
62.5%
5/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
27.1%
23/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.3%
11/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.6%
15/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.8%
6/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.1%
12/85
Eligible patients who started study treatment and had adverse events assessed are included. 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%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.5%
15/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.3%
13/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.1%
6/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Ataxia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.8%
6/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.6%
9/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cognitive disturbance
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.0%
10/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.9%
11/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Concentration impairment
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
23.4%
18/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.1%
12/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.8%
16/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
29.4%
25/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
55.6%
5/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
87.5%
7/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
53.2%
41/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
47.1%
40/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Memory impairment
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.8%
26/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.3%
13/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.2%
14/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.1%
6/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Paresthesia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Seizure
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.3%
3/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.5%
15/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
18.8%
16/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Tremor
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.8%
6/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.2%
7/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Agitation
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.9%
5/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.9%
13/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.9%
11/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Confusion
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.0%
10/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.1%
12/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
19.5%
15/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.9%
11/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
50.0%
4/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
24.7%
19/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.0%
17/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Personality change
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Restlessness
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Suicidal ideation
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary frequency
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary tract pain
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.5%
5/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
75.0%
6/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
87.5%
7/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.1%
44/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
57.6%
49/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.1%
1/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.4%
8/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.7%
4/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.3%
1/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
2/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.5%
3/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.5%
5/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.4%
8/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.2%
2/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.1%
12/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
2/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. 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
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.1%
7/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.2%
7/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.6%
2/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.5%
3/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.9%
3/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.2%
7/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.2%
4/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.1%
6/85
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Vascular disorders - Other
|
12.5%
1/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/9
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/8
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/77
Eligible patients who started study treatment and had adverse events assessed are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.2%
1/85
Eligible patients who started study treatment and had adverse events assessed are included. 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 PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER