Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer (NCT NCT02006667)
NCT ID: NCT02006667
Last Updated: 2015-02-11
Results Overview
PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
Results posted on
2015-02-11
Participant Flow
Participant milestones
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
Participants received gemcitabine 1200 milligrams per square meter (mg/m\^2), intravenously (IV), on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
Participants received gemcitabine 1200 milligrams per square meter (mg/m\^2), intravenously (IV), on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 Participants
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
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Age, Continuous
|
68.4 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 monthsPopulation: FAS
PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.
Outcome measures
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 Participants
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
|
Progression-Free Survival (PFS) - Percentage of Participants With an Event
|
92.3 percentage of participants
|
PRIMARY outcome
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 monthsPopulation: FAS
The median time, in months, from the first dose of study treatment to PFS event.
Outcome measures
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 Participants
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
|
Progression-Free Survival - Time to Event
|
11.0 months
Interval 5.7 to 14.3
|
PRIMARY outcome
Timeframe: Screening, and Months 12 and 24Population: FAS
Outcome measures
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 Participants
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
|
Percentage of Participants Who Were Progression Free at 12 and 24 Months
12 Months
|
38.5 percentage of participants
Interval 14.1 to 62.8
|
|
Percentage of Participants Who Were Progression Free at 12 and 24 Months
24 Months
|
15.4 percentage of participants
Interval 2.5 to 38.8
|
SECONDARY outcome
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 monthsPopulation: FAS
OS was defined as the time from the start of study treatment to date of death due to any cause.
Outcome measures
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 Participants
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
|
Overall Survival (OS) - Percentage of Participants With an Event
|
84.6 percentage of participants
|
SECONDARY outcome
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 monthsPopulation: FAS
The median time, in months, from the start of study treatment to OS event.
Outcome measures
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 Participants
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
|
Overall Survival - Time to Event
|
14.9 months
Interval 12.9 to 21.7
|
SECONDARY outcome
Timeframe: Screening, and Months 12 and 24Population: FAS
Outcome measures
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 Participants
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
|
Percentage of Participants Surviving at 12 and 24 Months
12 Months
|
76.9 percentage of participants
Interval 44.2 to 91.9
|
|
Percentage of Participants Surviving at 12 and 24 Months
24 Months
|
23.1 percentage of participants
Interval 5.6 to 47.5
|
SECONDARY outcome
Timeframe: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 monthsPopulation: FAS
Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal \[(short axis less than (\<) 10 millimeters (mm)\]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).
Outcome measures
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 Participants
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
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|---|---|
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Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
CR
|
15.4 percentage of participants
|
|
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
PR
|
23.1 percentage of participants
|
|
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
SD
|
46.2 percentage of participants
|
|
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
PD
|
15.4 percentage of participants
|
|
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
CR/PR
|
38.5 percentage of participants
|
|
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
CR/PR/SD
|
84.6 percentage of participants
|
Adverse Events
Trastuzumab/Gemcitabine/Cisplatin
Serious events: 8 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 participants at risk
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
|
|---|---|
|
Cardiac disorders
Tachyarrhythmia
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Gastrointestinal disorders
Gastrointestinal hermorrhage
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Gastrointestinal disorders
Ileus
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
Chill
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
Fatigue
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
Fever
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
General disorders-other
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Infections and infestations
Catheter related infection
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
Platelet count decreased
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
White blood cell decreased
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
Other adverse events
| Measure |
Trastuzumab/Gemcitabine/Cisplatin
n=13 participants at risk
Participants received gemcitabine 1200 mg/m\^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m\^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Cardiac disorders
Sinus bradycardia
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Endocrine disorders
Endocrine disorders-other
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Eye disorders
Eyelid function disorder
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
Chills
|
23.1%
3/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
Fatigue
|
23.1%
3/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
Pain
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
General disorders
General disorders and administration site conditions-other
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Infections and infestations
Bronchial infection
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Infections and infestations
Nail infection
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Infections and infestations
Infections and infestations-others
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
Creatinine increased
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
Weight loss
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
White blood cell decreased
|
23.1%
3/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
Platelet count decreased
|
46.2%
6/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
Investigations-other
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Investigations
Neutrophil count decreased
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified-others
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Nervous system disorders
Paresthesia
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.1%
3/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.4%
2/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
|
Surgical and medical procedures
Surgical and medical procedures-others
|
7.7%
1/13 • Adverse events were reported from randomization until 30 days after the end of treatment.
This study did not include a separate analysis of non-serious AE's. In addition, only events by system organ class were provided, no preferred terms for individual events were available.
|
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 that 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