Trial Outcomes & Findings for Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia (NCT NCT02956967)
NCT ID: NCT02956967
Last Updated: 2019-02-11
Results Overview
Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital). Percentage of participants with any ongoing comorbidities were reported in this outcome measure.
Recruitment status
COMPLETED
Target enrollment
171 participants
Primary outcome timeframe
Baseline (Day 1)
Results posted on
2019-02-11
Participant Flow
Participant milestones
| Measure |
Nivestim
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 microgram per day (mcg/day) as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Overall Study
STARTED
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171
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Overall Study
COMPLETED
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123
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Overall Study
NOT COMPLETED
|
48
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Reasons for withdrawal
| Measure |
Nivestim
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 microgram per day (mcg/day) as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Overall Study
Adverse Event
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3
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Overall Study
Reason non-related to neutropenia
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10
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Overall Study
Lost to Follow-up
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5
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Overall Study
Missing
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1
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Overall Study
Termination of Nivestim administration
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29
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Baseline Characteristics
Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Baseline characteristics by cohort
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Age, Continuous
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59.3 years
STANDARD_DEVIATION 11.36 • n=5 Participants
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Sex: Female, Male
Female
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143 Participants
n=5 Participants
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Sex: Female, Male
Male
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28 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital). Percentage of participants with any ongoing comorbidities were reported in this outcome measure.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Percentage of Participants With Any Significant Comorbidities
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42.7 percentage of participants
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PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Different types of Haematological malignancies included Hodgkin's lymphoma, leukemia (chronic lymphocytic leukemia), non-Hodgkin's lymphoma and other stem cell transformations. Percentage of participants with different type of ongoing haematological malignancies were reported in this outcome measure.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Percentage of Participants With Different Types of Haematological Malignancies
Hodgkin's lymphoma
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0.6 percentage of participants
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Percentage of Participants With Different Types of Haematological Malignancies
Leukemia
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1.2 percentage of participants
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Percentage of Participants With Different Types of Haematological Malignancies
Non-Hodgkin's lymphoma
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1.8 percentage of participants
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Percentage of Participants With Different Types of Haematological Malignancies
Other stem cell transformations
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1.2 percentage of participants
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PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Different types of solid tumour included tumour of a) Digestive organs such as colon, oesophagus, pancreas, stomach tumour b) Gynaecological organs such as breast, endometrium, ovaries tumour c) Lung organs such as non-small cell lung cancer and small cell lung cancer d) Urological organs such as bladder, prostate gland, testicles tumour e) other organ tumours. Percentage of participants with different types of ongoing solid tumour were reported in this outcome measure.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Percentage of Participants With Different Types of Solid Tumour
Urological: Testicles Tumour
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0.6 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Digestive organ: Colon/Rectum Tumour
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3.5 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Digestive organ: Oesophageal Tumour
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1.2 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Digestive organ: Pancreatic Tumour
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3.5 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Digestive organ: Stomach Tumour
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1.2 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Gynaecological: Breast Tumour
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66.7 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Gynaecological: Endometrial Tumour
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1.2 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Gynaecological: Ovarian Tumour
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4.1 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Lungs: Non-small cell lung cancer
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3.5 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Lungs: Small cell lung cancer
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1.8 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Urological: Bladder Tumour
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0.6 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Urological: Prostate Gland Tumour
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2.9 percentage of participants
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Percentage of Participants With Different Types of Solid Tumour
Other organ Tumour
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4.1 percentage of participants
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PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Time from diagnosis of any previous solid tumour in participants up to the enrolment in the study was recorded at baseline and reported in this outcome measure.
Outcome measures
| Measure |
Nivestim
n=163 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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Duration of Solid Tumour in Participants Prior to Enrolment in Study
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1.0 years
Standard Deviation 2.86 • Interval 0.0 to 1.0
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PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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Number of Participants Who Received Chemotherapy Prior to Enrolment in Study
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51 participants
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PRIMARY outcome
Timeframe: Baseline up to 6 monthsPopulation: The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to 6 monthsPopulation: The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.
Participants rated the overall satisfaction with Nivestim as part of a questionnaire. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. The satisfaction was rated on a scale ranging from 1 (minimum score) to 6 (maximum score), where higher scores indicated dissatisfaction with the treatment. For this outcome measure, the within-participant average scores are summarized.
Outcome measures
| Measure |
Nivestim
n=167 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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Participants' Overall Satisfaction Scores in Response to the Study Treatment
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1.9 units on a scale
Standard Deviation 0.85
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SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.
Participants evaluated the packaging of Nivestim as part of a questionnaire. The packaging was rated under the 2 available categories as either easy or complicated. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.
Outcome measures
| Measure |
Nivestim
n=169 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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Participant's Assessment for Nivestim Packaging
Easy
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144 participants
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Participant's Assessment for Nivestim Packaging
Complicated
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4 participants
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Participant's Assessment for Nivestim Packaging
Missing
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21 participants
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SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.
Participants evaluated the injection site pain and the injection site tolerability of the treatment as part of a questionnaire. The injection site pain was rated under the 5 available categories as: Did not feel anything, did not feel much, light stitch, painful and very painful. Injection site tolerability was also rated under the 5 available categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For both the injection site pain and tolerability, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category for each of them.
Outcome measures
| Measure |
Nivestim
n=169 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Participant's Assessment of Injection Site Pain and Tolerability
Injection Site Pain: Did not feel anything
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53 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Injection Site Pain: Did not feel much
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128 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Injection Site Pain: Light stitch
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42 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Injection Site Pain: Painful
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4 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Injection Site Pain: Very painful
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0 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Tolerability: Very good
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107 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Tolerability: Good
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106 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Tolerability: Satisfactory
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12 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Tolerability: Did not tolerate well
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4 participants
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Participant's Assessment of Injection Site Pain and Tolerability
Tolerability: Did not tolerate at all
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0 participants
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SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.
Participants evaluated the overall tolerability of subcutaneous injection of treatment as part of a questionnaire. The tolerability was rated under the 5 categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.
Outcome measures
| Measure |
Nivestim
n=169 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Participant's Assessment of Overall Tolerability of Subcutaneous Injection
Very good
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75 participants
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Participant's Assessment of Overall Tolerability of Subcutaneous Injection
Good
|
117 participants
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Participant's Assessment of Overall Tolerability of Subcutaneous Injection
Satisfactory
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20 participants
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Participant's Assessment of Overall Tolerability of Subcutaneous Injection
Did not tolerate well
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14 participants
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Participant's Assessment of Overall Tolerability of Subcutaneous Injection
Did not tolerate at all
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3 participants
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SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Percentage of participants with absolute neutrophil count (greater than)\>0.5\*10\^9 Neutrophils per Liter were reported in this outcome measure.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Percentage of Participants With Neutropenia
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0.0 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Infections included bronchitis, upper respiratory tract infection, cystitis, herpes virus infection, influenza, lung infection, oral candidiasis, skin infection and vulvovaginal mycotic infection. Serious Infections included serious adverse events resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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Percentage of Participants With at Least One Infection and Serious Infection
Infection
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8.2 percentage of participants
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Percentage of Participants With at Least One Infection and Serious Infection
Serious Infection
|
1.8 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Cycle 1, 2, 3, 4, 5, 6Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, number analyzed (n) signifies those participants who were evaluable at specified time points only.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Baseline
|
3.36 10^9 Neutrophils per Liter
Standard Deviation 3.005
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Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Change at Cycle 1
|
-0.03 10^9 Neutrophils per Liter
Standard Deviation 0.528
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Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Change at Cycle 2
|
1.76 10^9 Neutrophils per Liter
Standard Deviation 5.304
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Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Change at Cycle 3
|
1.35 10^9 Neutrophils per Liter
Standard Deviation 4.787
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|
Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Change at Cycle 4
|
3.49 10^9 Neutrophils per Liter
Standard Deviation 1.924
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Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Change at Cycle 5
|
4.50 10^9 Neutrophils per Liter
Standard Deviation 4.107
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|
Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Change at Cycle 6
|
1.00 10^9 Neutrophils per Liter
Standard Deviation 1.556
|
SECONDARY outcome
Timeframe: Cycle 1, 2, 3, 4, 5, 6Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Minimum Value of Absolute Neutrophil Count
Cycle 1
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2.49 10^9 Neutrophils per Liter
Standard Deviation 3.271
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Minimum Value of Absolute Neutrophil Count
Cycle 2
|
3.12 10^9 Neutrophils per Liter
Standard Deviation 3.485
|
|
Minimum Value of Absolute Neutrophil Count
Cycle 3
|
2.95 10^9 Neutrophils per Liter
Standard Deviation 3.015
|
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Minimum Value of Absolute Neutrophil Count
Cycle 4
|
4.90 10^9 Neutrophils per Liter
Standard Deviation 1.941
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|
Minimum Value of Absolute Neutrophil Count
Cycle 5
|
9.20 10^9 Neutrophils per Liter
Standard Deviation NA
As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.
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Minimum Value of Absolute Neutrophil Count
Cycle 6
|
4.15 10^9 Neutrophils per Liter
Standard Deviation 0.354
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SECONDARY outcome
Timeframe: End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Cycle 5
|
0.70 10^9 Neutrophils per Liter
Standard Deviation NA
As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.
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|
Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Cycle 6
|
46.15 10^9 Neutrophils per Liter
Standard Deviation 51.831
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|
Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Cycle 1
|
8.22 10^9 Neutrophils per Liter
Standard Deviation 9.874
|
|
Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Cycle 2
|
6.50 10^9 Neutrophils per Liter
Standard Deviation 6.297
|
|
Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Cycle 3
|
6.52 10^9 Neutrophils per Liter
Standard Deviation 7.570
|
|
Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Cycle 4
|
1.78 10^9 Neutrophils per Liter
Standard Deviation 0.873
|
SECONDARY outcome
Timeframe: Cycle 1, 2, 3, 4, 5, 6Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
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|---|---|
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Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Cycle 1
|
6.18 10^9 Neutrophils per Liter
Standard Deviation 9.548
|
|
Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Cycle 2
|
3.26 10^9 Neutrophils per Liter
Standard Deviation 5.872
|
|
Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Cycle 3
|
3.70 10^9 Neutrophils per Liter
Standard Deviation 7.450
|
|
Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Cycle 4
|
-3.13 10^9 Neutrophils per Liter
Standard Deviation 2.653
|
|
Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Cycle 5
|
-8.50 10^9 Neutrophils per Liter
Standard Deviation NA
As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.
|
|
Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Cycle 6
|
42.00 10^9 Neutrophils per Liter
Standard Deviation 52.184
|
SECONDARY outcome
Timeframe: Cycle 1, 2, 3, 4, 5, 6Population: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
|
|---|---|
|
Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Cycle 1
|
5.0 days
Interval -9.0 to 28.0
|
|
Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Cycle 2
|
4.0 days
Interval -17.0 to 41.0
|
|
Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Cycle 3
|
4.0 days
Interval -9.0 to 18.0
|
|
Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Cycle 4
|
6.0 days
Interval 5.0 to 7.0
|
|
Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Cycle 5
|
9.0 days
Interval 9.0 to 9.0
|
|
Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Cycle 6
|
5.5 days
Interval 5.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Grade 3/4 febrile neutropenia is defined as a temperature of greater than or equal to (\>=) 38.0 degree Celsius and absolute neutrophil count of less than (\<) 1.0 × 10\^9 Neutrophils per Liter.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
|
|---|---|
|
Percentage of Participants With Febrile Neutropenia
|
0.6 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 6 monthsPopulation: Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
Outcome measures
| Measure |
Nivestim
n=171 Participants
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
81 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
16 Participants
|
Adverse Events
Nivestim
Serious events: 16 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivestim
n=171 participants at risk
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
|
|---|---|
|
General disorders
Chest pain
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.5%
6/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
General physical health deterioration
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Infection
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Diverticulitis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Haematuria
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Nivestim
n=171 participants at risk
Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.
|
|---|---|
|
General disorders
Mucosal Inflammation
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
16/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
7/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Stomatitis
|
3.5%
6/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
4/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dry mouth
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Flatulence
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastritis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Toothache
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
14/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.7%
8/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
2.3%
4/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chills
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Influenza like illness
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site erythema
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Malaise
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Mucosal toxicity
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Peripheral swelling
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.7%
8/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
7/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.5%
6/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
2.3%
4/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dysgeusia
|
1.8%
3/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dysaesthesia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Polyneuropathy
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Syncope
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cystitis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpes virus infection
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Infection
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Influenza
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Lung infection
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral Candidiasis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Skin infection
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Platelet count increased
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood glucose increased
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood pressure increased
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count decreased
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight increased
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
White blood cell count decreased
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Tachycardia
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hot flush
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
2/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Blepharospasm
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Visual Impairment
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hyperthyroidism
|
0.58%
1/171 • Baseline up to 6 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER