Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer (NCT NCT00661778)
NCT ID: NCT00661778
Last Updated: 2014-07-10
Results Overview
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline to the end of the study (up to 4 years)
Results posted on
2014-07-10
Participant Flow
The data listed in Participant Flow are for discontinuation from treatment, not discontinuation from the study. Data for discontinuation from the study are not available.
Participant milestones
| Measure |
Bevacizumab + Cisplatin + Docetaxel
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Bevacizumab + Cisplatin + Docetaxel
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Study
Disease Progression
|
23
|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Reason not Specified
|
6
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal of Consent
|
1
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab + Cisplatin + Docetaxel
n=50 Participants
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Age, Continuous
|
58.31 Years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of the study (up to 4 years)Population: Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
Outcome measures
| Measure |
Bevacizumab + Cisplatin + Docetaxel
n=49 Participants
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Progression-free Survival
|
8.95 Months
Interval 6.92 to 9.97
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years)Population: Evaluable population: All participants who received at least 2 treatment cycles, have had all baseline lesions assessed on at least 1 occasion after receiving the 2nd treatment cycle, and have not had any major protocol violations.
An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
Outcome measures
| Measure |
Bevacizumab + Cisplatin + Docetaxel
n=46 Participants
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Percentage of Participants With an Objective Response
|
67.39 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years)Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years)Population: Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
Overall survival is defined as the time from the first dose of study medication until death.
Outcome measures
| Measure |
Bevacizumab + Cisplatin + Docetaxel
n=46 Participants
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Survival
|
12.74 Months
Interval 9.48 to 17.79
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: Per protocol population: All participants who received at least 1 dose of study medication and had no major protocol deviations.
The probability of surviving 1 year was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + Cisplatin + Docetaxel
n=46 Participants
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
1-year Survival
|
53.46 Percentage of participants
Interval 39.19 to 67.45
|
Adverse Events
Bevacizumab + Cisplatin + Docetaxel
Serious events: 26 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Cisplatin + Docetaxel
n=49 participants at risk
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Neutrophil count increased
|
12.2%
6/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Positron emission tomography
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased leukocyte count
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Respiratory tract infection
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Oral candidiasis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Anal abscess
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Infection
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Surgical and medical procedures
Appendectomy
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Cardiac disorders
Palpitations
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.2%
5/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Pyrexia
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Mucosal inflammation
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Reaction at the injection site
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Asthenia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Death
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
Other adverse events
| Measure |
Bevacizumab + Cisplatin + Docetaxel
n=49 participants at risk
Participants received bevacizumab 15 mg/kg intravenously (IV) followed by docetaxel 75 mg/kg IV in combination with cisplatin 75 mg/m\^2 IV on Day 1 of each 3-week cycle for a maximum of 6 cycles. After completing the 6 cycles of combined chemotherapy, participants received bevacizumab 15 mg/kg IV until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Investigations
Decreased hemoglobin
|
42.9%
21/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
High neutrophil count
|
28.6%
14/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased platelet count
|
22.4%
11/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated blood creatinine
|
20.4%
10/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased leukocyte count
|
18.4%
9/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Gamma glutamyltransferase
|
14.3%
7/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated alanine aminotransferase
|
8.2%
4/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased total protein
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased lymphocyte count
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Abnormal transaminases
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated blood urea
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Urinary urobilin
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased neutrophil count
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated leukocyte count
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Increased blood alkaline phosphatase
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated gamma glutamyl transferase
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated blood lactate dehydrogenase
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated blood bilirubin
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Blood urea
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased monocyte count
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Hipofonesis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated triglycerides in blood
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated ferritin in serum
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Positron emission tomography
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Alanine aminotransferase
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Abnormal coagulation test
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Increased international normalised ratio
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Prolonged activated partial thromboplastin time
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased blood creatinine
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Decreased calcium in blood
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
White blood count
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Lymphocyte count
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Investigations
Elevated aspartate aminotransferase
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Respiratory tract infection
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Infection
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Pneumonia
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Oral candidiasis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Tooth infection
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Furuncle
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Parotiditis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Oral infection
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Infections and infestations
Anal abscess
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Surgical and medical procedures
Appendectomy
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Cardiac disorders
Palpitations
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.9%
22/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Ungueal toxicity
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Cutaneous toxicity
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation of the skin
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.2%
5/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Blood and lymphatic system disorders
Bone marrow depression
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Reproductive system and breast disorders
Amenorrhea
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Anorexia
|
34.7%
17/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.4%
11/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
7/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Hypokalemia
|
10.2%
5/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
10.2%
5/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hyperpotassemia
|
10.2%
5/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.2%
4/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Nervous system disorders
Neuropathy
|
26.5%
13/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Nervous system disorders
Dysgeusia
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Nervous system disorders
Headache
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Nervous system disorders
Paresthesia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Nervous system disorders
Syncope
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Nervous system disorders
Decreased consciousness
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
55.1%
27/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
38.8%
19/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
36.7%
18/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
22.4%
11/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
16.3%
8/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
4/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Odynophagia
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Oesophagitis
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Rectal bleeding
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Retching
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Hematemesis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Proctalgia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Fatigue
|
73.5%
36/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Mucosal inflammation
|
42.9%
21/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Pyrexia
|
30.6%
15/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Pain
|
12.2%
6/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Asthenia
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Edema
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Reaction at the injection site
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Peripheral edema
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Chest pain
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Extravasation
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
General disorders
Death
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
5/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
4/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in one extremity
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in the chest wall
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in sacrum
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Eye disorders
Increased lacrimation
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Eye disorders
Conjunctivitis
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Psychiatric disorders
Anxiety
|
8.2%
4/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Psychiatric disorders
Depression
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Psychiatric disorders
Disorientation
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
7/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
38.8%
19/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.4%
10/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
4/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.1%
3/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Perforation of the nasal septum
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccupping
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnea
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Vascular disorders
Hypertension
|
16.3%
8/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Vascular disorders
Phlebitis
|
8.2%
4/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
4.1%
2/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Vascular disorders
Hypotension
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Vascular disorders
Flushing
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
|
Vascular disorders
Haemorrhage
|
2.0%
1/49
Safety population: All enrolled participants who received at least 1 treatment and who satisfied all inclusion criteria and none of the exclusion criteria. One participant satisfied an exclusion criterion and was not included in the safety population.
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800 821-8590
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