Trial Outcomes & Findings for Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (NCT NCT01745367)
NCT ID: NCT01745367
Last Updated: 2020-10-27
Results Overview
PFS is defined as the time from randomization to progressive disease (PD) or death. The PFS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
approximately 24 months
Results posted on
2020-10-27
Participant Flow
Participants who met all the inclusion and none of the exclusion criteria were enrolled
All participants underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures. The study was terminated prior to completing enrollment, hence descriptive statistical analyses were performed for a limited set of data.
Participant milestones
| Measure |
Placebo in Combination With Paclitaxel
Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
Tivozanib Hydrochloride in Combination With Paclitaxel
Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
22
|
|
Overall Study
Treated
|
8
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
22
|
Reasons for withdrawal
| Measure |
Placebo in Combination With Paclitaxel
Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
Tivozanib Hydrochloride in Combination With Paclitaxel
Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Termination of The Study by The Sponsor
|
6
|
18
|
|
Overall Study
Other Reasons Unspecified
|
0
|
2
|
Baseline Characteristics
Tivozanib in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Placebo in Combination With Paclitaxel
n=8 Participants
Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
Tivozanib Hydrochloride in Combination With Paclitaxel
n=22 Participants
Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 16.02 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 10.06 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 12.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Dominican
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Body Mass Index
|
30.6 kg/m^2
STANDARD_DEVIATION 10.67 • n=5 Participants
|
182.3 kg/m^2
STANDARD_DEVIATION 708.53 • n=7 Participants
|
144.4 kg/m^2
STANDARD_DEVIATION 613.48 • n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 24 monthsPopulation: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
PFS is defined as the time from randomization to progressive disease (PD) or death. The PFS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. DoR is defined as the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The ORR and DoR comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
OS measures how long subjects, who undergo a certain treatment regimen, live compared to subjects who are in a control group (i.e., taking either another drug or an inactive treatment, known as a placebo). OS comparison was performed for subjects treated with tivozanib hydrochloride in combination with paclitaxel vs placebo in combination with paclitaxel.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: Descriptive statistical analyses were performed for a limited set of data (disposition, demographics, and adverse events).
Number of subjects with serious and non-serious adverse events.
Outcome measures
| Measure |
Tivozanib Hydrochloride in Combination With Paclitaxel
n=21 Participants
1.5 mg tivozanib hydrochloride orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
|
Placebo in Combination With Paclitaxel
n=8 Participants
Placebo orally once daily for 3 weeks followed by 1 week off and 90 mg/m2 of paclitaxel administered intravenously on weeks 1, 2 and 3 (Day 1, Day 8 and Day 15) of a 4-week cycle.
|
|---|---|---|
|
Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel
Subjects with serious adverse events
|
1 Participants
|
1 Participants
|
|
Safety and Tolerability of Tivozanib Hydrochloride in Combination With Paclitaxel vs Placebo in Combination With Paclitaxel
Subjects with non-serious adverse events
|
19 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
PK is defined as the study of the bodily absorption, distribution, metabolism, and excretion of drugs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Pre-dose and 2, 4 and 24 hours post dose; Cycle 1, Day 8: Pre-dose; Cycle 1, Day 21: Pre-dose and 2, 4, 24, 48, and 96 hours post dose; Cycle 2 (Day 1): Pre-dosePopulation: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
Evaluation of hypoxia gene signature as a predictive biomarker of tivozanib hydrochloride response and establish the optimal cut-off to identify biomarker positive and negative subgroups. The genes comprising the hypoxia gene signature was analyzed in tumor tissue from subjects.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: approximately 24 monthsPopulation: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Euro Quality of Life - 5 Dimensions (EQ-5D) questionnaires was used throughout the study to measure subjects' health-related QoL.
Outcome measures
Outcome data not reported
Adverse Events
Placebo in Combination With Paclitaxel
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Tivozanib Hydrochloride in Combination With Paclitaxel
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo in Combination With Paclitaxel
n=8 participants at risk
Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
Tivozanib Hydrochloride in Combination With Paclitaxel
n=21 participants at risk
Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
4.8%
1/21 • Number of events 1 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
4.8%
1/21 • Number of events 1 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
General disorders
Fatigue
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
4.8%
1/21 • Number of events 1 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
4.8%
1/21 • Number of events 2 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
12.5%
1/8 • Number of events 1 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
Other adverse events
| Measure |
Placebo in Combination With Paclitaxel
n=8 participants at risk
Participants received placebo orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
Tivozanib Hydrochloride in Combination With Paclitaxel
n=21 participants at risk
Participants received 1.5 mg tivozanib hydrochloride orally once daily with 90 mg/m2 of paclitaxel administered intravenously beginning on Day 1 for 3 weeks followed by 1 week off treatment.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
4/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
33.3%
7/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Skin and subcutaneous tissue disorders
Pruritis Genralized
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
19.0%
4/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
42.9%
9/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
28.6%
6/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
28.6%
6/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
23.8%
5/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
General disorders
Faitgue
|
50.0%
4/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
52.4%
11/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
General disorders
Oedema peripheral
|
25.0%
2/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
General disorders
Asthenia
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
3/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
23.8%
5/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
2/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
38.1%
8/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Investigations
Liver function test abnormal
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Investigations
Platelet count increased
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Investigations
Lipase increased
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
2/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
19.0%
4/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
19.0%
4/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
23.8%
5/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Nervous system disorders
Presyncope
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Infections and infestations
Bronchitis
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Infections and infestations
Rash pustular
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
42.9%
9/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
23.8%
5/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Ear and labyrinth disorders
Vertigo
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Eye disorders
Ocular hyperaemia
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Injury, poisoning and procedural complications
Laceration
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Reproductive system and breast disorders
Pelvic pain
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Vascular disorders
Poor venous access
|
12.5%
1/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
0.00%
0/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
33.3%
7/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Endocrine disorders
Endocrine disorders
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
14.3%
3/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
9.5%
2/21 • 14 months
Serious treatment-emergent adverse events and treatment emergent adverse events in Safety Population was reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place