Trial Outcomes & Findings for A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme (NCT NCT01115491)
NCT ID: NCT01115491
Last Updated: 2014-12-08
Results Overview
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks
Results posted on
2014-12-08
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Temozolomide
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg per square meter (mg/m\^2), orally (PO), on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Bevacizumab + Temozolomide
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg per square meter (mg/m\^2), orally (PO), on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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Overall Study
Death
|
22
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Bevacizumab + Temozolomide
n=32 Participants
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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Age, Continuous
|
56.19 years
STANDARD_DEVIATION 10.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeksPopulation: ITT population
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.
Outcome measures
| Measure |
Bevacizumab + Temozolomide
n=32 Participants
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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Progression-Free Survival (PFS) - Percentage of Participants With an Event
|
96.88 percentage of participants
|
PRIMARY outcome
Timeframe: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeksPopulation: ITT population
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + Temozolomide
n=32 Participants
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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PFS - Time to Event
|
18.29 weeks
Interval 15.43 to 23.57
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PRIMARY outcome
Timeframe: BL, 24 weeks (after 6th cycle)Population: ITT population
Outcome measures
| Measure |
Bevacizumab + Temozolomide
n=32 Participants
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study
|
0.30000 survival probability
0.0819
|
SECONDARY outcome
Timeframe: BL, every 28 days, until death or end-of-study, an average of 32 weeksPopulation: ITT population
Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.
Outcome measures
| Measure |
Bevacizumab + Temozolomide
n=32 Participants
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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Overall Survival - Percentage of Participants With an Event
|
75.00 percentage of participants
|
SECONDARY outcome
Timeframe: BL, every 28 days, until death or end-of-study, an average of 32 weeksPopulation: ITT population
Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + Temozolomide
n=32 Participants
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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Overall Survival - Time to Event
|
31.43 weeks
Interval 25.14 to 38.29
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SECONDARY outcome
Timeframe: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeksPopulation: ITT population
Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.
Outcome measures
| Measure |
Bevacizumab + Temozolomide
n=32 Participants
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
|
40.6 percentage of participants
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Adverse Events
Bevacizumab + Temozolomide
Serious events: 8 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Temozolomide
n=32 participants at risk
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
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|---|---|
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Infections and infestations
Lung (pneumonia)
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
1/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
General disorders
Fever
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Neurological disorder NOS
|
3.1%
1/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Seizures
|
3.1%
1/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Vascular disorders
Thrombosis
|
3.1%
1/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Renal and urinary disorders
Bladder haemorrhage
|
3.1%
1/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Blood and lymphatic system disorders
Intracranial haemorrhage
|
3.1%
1/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
Other adverse events
| Measure |
Bevacizumab + Temozolomide
n=32 participants at risk
Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m\^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.
Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.
|
|---|---|
|
Nervous system disorders
Olfactory nerve disorder
|
28.1%
9/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Neurological disorder NOS
|
15.6%
5/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Seizures
|
12.5%
4/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Depressed level of consciousness
|
15.6%
5/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Central nervous system necrosis
|
12.5%
4/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Speech disorder
|
12.5%
4/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Ataxia
|
15.6%
5/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Memory impairment
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Mood alteration
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Cognitive disturbance
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
50.0%
16/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
46.9%
15/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
18.8%
6/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Blood and lymphatic system disorders
Leukocyte count decreased
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
General disorders
Fatigue
|
56.2%
18/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
General disorders
Fever
|
12.5%
4/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
General disorders
General symptom
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
34.4%
11/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
8/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
6/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
6/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.6%
5/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
8/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
15.6%
5/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Infections and infestations
Bronchitis
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Infections and infestations
Lung (pneumonia)
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Infections and infestations
Upper aerodigestive tract infection
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Nervous system disorders
Headache
|
28.1%
9/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Vascular disorders
Hypertension
|
21.9%
7/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycaemia)
|
15.6%
5/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
General disorders
Haemorrhage
|
12.5%
4/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Blood and lymphatic system disorders
Oedema limbs
|
15.6%
5/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
6.2%
2/32 • Adverse events (AEs) were collected from the date of start of study treatment to 90 days after the last dose of study treatment.
All participants who received at least 1 dose of study treatment were included in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER