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Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956967
Recruitment Status : Completed
First Posted : November 6, 2016
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Non-Interventional Study
Intervention Other: Overall satisfaction questionnaires of home use of Nivestim
Enrollment 171
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nivestim
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 171
Completed 123
Not Completed 48
Reason Not Completed
Adverse Event             3
Reason non-related to neutropenia             10
Lost to Follow-up             5
Missing             1
Termination of Nivestim administration             29
Arm/Group Title Nivestim
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 171
Hide Baseline Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in electronic case report form (eCRF).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants
59.3  (11.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants
Female
143
  83.6%
Male
28
  16.4%
1.Primary Outcome
Title Percentage of Participants With Any Significant Comorbidities
Hide Description 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.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: percentage of participants
42.7
2.Primary Outcome
Title Percentage of Participants With Different Types of Haematological Malignancies
Hide Description 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.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: percentage of participants
Hodgkin's lymphoma 0.6
Leukemia 1.2
Non-Hodgkin's lymphoma 1.8
Other stem cell transformations 1.2
3.Primary Outcome
Title Percentage of Participants With Different Types of Solid Tumour
Hide Description 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.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: percentage of participants
Digestive organ: Colon/Rectum Tumour 3.5
Digestive organ: Oesophageal Tumour 1.2
Digestive organ: Pancreatic Tumour 3.5
Digestive organ: Stomach Tumour 1.2
Gynaecological: Breast Tumour 66.7
Gynaecological: Endometrial Tumour 1.2
Gynaecological: Ovarian Tumour 4.1
Lungs: Non-small cell lung cancer 3.5
Lungs: Small cell lung cancer 1.8
Urological: Bladder Tumour 0.6
Urological: Prostate Gland Tumour 2.9
Urological: Testicles Tumour 0.6
Other organ Tumour 4.1
4.Primary Outcome
Title Duration of Solid Tumour in Participants Prior to Enrolment in Study
Hide Description 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.
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 163
Mean (Standard Deviation)
Unit of Measure: years
1.0  (2.86)
5.Primary Outcome
Title Number of Participants Who Received Chemotherapy Prior to Enrolment in Study
Hide Description [Not Specified]
Time Frame Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: participants
51
6.Primary Outcome
Title Duration of Different Types of Chemotherapies Received by Participants During Study
Hide Description [Not Specified]
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Primary Outcome
Title Percentage of Participants With Response to Study Treatment
Hide Description [Not Specified]
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Participants' Overall Satisfaction Scores in Response to the Study Treatment
Hide Description 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.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 167
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (0.85)
9.Secondary Outcome
Title Participant's Assessment for Nivestim Packaging
Hide Description 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.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 169
Measure Type: Number
Unit of Measure: participants
Easy 144
Complicated 4
Missing 21
10.Secondary Outcome
Title Participant's Assessment of Injection Site Pain and Tolerability
Hide Description 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.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 169
Measure Type: Number
Unit of Measure: participants
Injection Site Pain: Did not feel anything 53
Injection Site Pain: Did not feel much 128
Injection Site Pain: Light stitch 42
Injection Site Pain: Painful 4
Injection Site Pain: Very painful 0
Tolerability: Very good 107
Tolerability: Good 106
Tolerability: Satisfactory 12
Tolerability: Did not tolerate well 4
Tolerability: Did not tolerate at all 0
11.Secondary Outcome
Title Participant's Assessment of Overall Tolerability of Subcutaneous Injection
Hide Description 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.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 169
Measure Type: Number
Unit of Measure: participants
Very good 75
Good 117
Satisfactory 20
Did not tolerate well 14
Did not tolerate at all 3
12.Secondary Outcome
Title Percentage of Participants With Neutropenia
Hide Description Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9 Neutrophils per Liter were reported in this outcome measure.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: percentage of participants
0.0
13.Secondary Outcome
Title Percentage of Participants With at Least One Infection and Serious Infection
Hide Description 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.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: percentage of participants
Infection 8.2
Serious Infection 1.8
14.Secondary Outcome
Title Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6
Hide Description [Not Specified]
Time Frame Baseline, Cycle 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Mean (Standard Deviation)
Unit of Measure: 10^9 Neutrophils per Liter
Baseline Number Analyzed 118 participants
3.36  (3.005)
Change at Cycle 1 Number Analyzed 86 participants
-0.03  (0.528)
Change at Cycle 2 Number Analyzed 92 participants
1.76  (5.304)
Change at Cycle 3 Number Analyzed 85 participants
1.35  (4.787)
Change at Cycle 4 Number Analyzed 7 participants
3.49  (1.924)
Change at Cycle 5 Number Analyzed 3 participants
4.50  (4.107)
Change at Cycle 6 Number Analyzed 2 participants
1.00  (1.556)
15.Secondary Outcome
Title Minimum Value of Absolute Neutrophil Count
Hide Description [Not Specified]
Time Frame Cycle 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Mean (Standard Deviation)
Unit of Measure: 10^9 Neutrophils per Liter
Cycle 1 Number Analyzed 89 participants
2.49  (3.271)
Cycle 2 Number Analyzed 65 participants
3.12  (3.485)
Cycle 3 Number Analyzed 66 participants
2.95  (3.015)
Cycle 4 Number Analyzed 4 participants
4.90  (1.941)
Cycle 5 Number Analyzed 1 participants
9.20 [1]   (NA)
Cycle 6 Number Analyzed 2 participants
4.15  (0.354)
[1]
As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.
16.Secondary Outcome
Title Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle
Hide Description [Not Specified]
Time Frame End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Mean (Standard Deviation)
Unit of Measure: 10^9 Neutrophils per Liter
Cycle 1 Number Analyzed 71 participants
8.22  (9.874)
Cycle 2 Number Analyzed 62 participants
6.50  (6.297)
Cycle 3 Number Analyzed 65 participants
6.52  (7.570)
Cycle 4 Number Analyzed 4 participants
1.78  (0.873)
Cycle 5 Number Analyzed 1 participants
0.70 [1]   (NA)
Cycle 6 Number Analyzed 2 participants
46.15  (51.831)
[1]
As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.
17.Secondary Outcome
Title Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count
Hide Description [Not Specified]
Time Frame Cycle 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Mean (Standard Deviation)
Unit of Measure: 10^9 Neutrophils per Liter
Cycle 1 Number Analyzed 66 participants
6.18  (9.548)
Cycle 2 Number Analyzed 58 participants
3.26  (5.872)
Cycle 3 Number Analyzed 59 participants
3.70  (7.450)
Cycle 4 Number Analyzed 4 participants
-3.13  (2.653)
Cycle 5 Number Analyzed 1 participants
-8.50 [1]   (NA)
Cycle 6 Number Analyzed 2 participants
42.00  (52.184)
[1]
As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.
18.Secondary Outcome
Title Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count
Hide Description [Not Specified]
Time Frame Cycle 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Median (Full Range)
Unit of Measure: days
Cycle 1 Number Analyzed 90 participants
5.0
(-9 to 28)
Cycle 2 Number Analyzed 65 participants
4.0
(-17 to 41)
Cycle 3 Number Analyzed 69 participants
4.0
(-9 to 18)
Cycle 4 Number Analyzed 3 participants
6.0
(5 to 7)
Cycle 5 Number Analyzed 1 participants
9.0
(9.0 to 9.0)
Cycle 6 Number Analyzed 2 participants
5.5
(5.0 to 6.0)
19.Secondary Outcome
Title Percentage of Participants With Febrile Neutropenia
Hide Description 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.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Measure Type: Number
Unit of Measure: percentage of participants
0.6
20.Other Pre-specified Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.
Arm/Group Title Nivestim
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 171
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
81
  47.4%
SAEs
16
   9.4%
Time Frame Baseline up to 6 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Nivestim
Hide Arm/Group Description 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.
All-Cause Mortality
Nivestim
Affected / at Risk (%)
Total   0/171 (0.00%) 
Hide Serious Adverse Events
Nivestim
Affected / at Risk (%)
Total   16/171 (9.36%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  1/171 (0.58%) 
Leukocytosis * 1  1/171 (0.58%) 
Pancytopenia * 1  6/171 (3.51%) 
Anaemia * 1  2/171 (1.17%) 
Leukopenia * 1  1/171 (0.58%) 
Thrombocytopenia * 1  1/171 (0.58%) 
Gastrointestinal disorders   
Diarrhoea * 1  2/171 (1.17%) 
General disorders   
Chest pain * 1  2/171 (1.17%) 
Pain * 1  1/171 (0.58%) 
General physical health deterioration * 1  2/171 (1.17%) 
Infections and infestations   
Infection * 1  2/171 (1.17%) 
Diverticulitis * 1  1/171 (0.58%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/171 (0.58%) 
Hypocalcaemia * 1  1/171 (0.58%) 
Musculoskeletal and connective tissue disorders   
Bone pain * 1  1/171 (0.58%) 
Back pain * 1  2/171 (1.17%) 
Athralgia * 1  1/171 (0.58%) 
Renal and urinary disorders   
Haematuria * 1  1/171 (0.58%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea exertional * 1  1/171 (0.58%) 
Vascular disorders   
Jugular vein thrombosis * 1  1/171 (0.58%) 
1
Term from vocabulary, MedDRA v19.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nivestim
Affected / at Risk (%)
Total   74/171 (43.27%) 
Blood and lymphatic system disorders   
Leukopenia * 1  8/171 (4.68%) 
Anaemia * 1  7/171 (4.09%) 
Thrombocytopenia * 1  3/171 (1.75%) 
Cytopenia * 1  1/171 (0.58%) 
Cardiac disorders   
Tachycardia * 1  2/171 (1.17%) 
Cardiovascular disorder * 1  1/171 (0.58%) 
Cardiovascular insufficiency * 1  1/171 (0.58%) 
Ear and labyrinth disorders   
Vertigo * 1  1/171 (0.58%) 
Endocrine disorders   
Hyperthyroidism * 1  1/171 (0.58%) 
Eye disorders   
Blepharospasm * 1  1/171 (0.58%) 
Visual Impairment * 1  1/171 (0.58%) 
Gastrointestinal disorders   
Nausea * 1  16/171 (9.36%) 
Vomiting * 1  7/171 (4.09%) 
Stomatitis * 1  6/171 (3.51%) 
Diarrhoea * 1  4/171 (2.34%) 
Dyspepsia * 1  3/171 (1.75%) 
Constipation * 1  2/171 (1.17%) 
Dry mouth * 1  1/171 (0.58%) 
Dysphagia * 1  1/171 (0.58%) 
Flatulence * 1  1/171 (0.58%) 
Gastritis * 1  1/171 (0.58%) 
Gastrooesophageal reflux disease * 1  1/171 (0.58%) 
Gingival bleeding * 1  1/171 (0.58%) 
Toothache * 1  1/171 (0.58%) 
General disorders   
Pyrexia * 1  4/171 (2.34%) 
Fatigue * 1  3/171 (1.75%) 
Mucosal Inflammation * 1  3/171 (1.75%) 
Oedema peripheral * 1  3/171 (1.75%) 
Pain * 1  3/171 (1.75%) 
Asthenia * 1  2/171 (1.17%) 
Chills * 1  1/171 (0.58%) 
Influenza like illness * 1  1/171 (0.58%) 
Injection site erythema * 1  1/171 (0.58%) 
Malaise * 1  1/171 (0.58%) 
Mucosal toxicity * 1  1/171 (0.58%) 
Peripheral swelling * 1  1/171 (0.58%) 
Infections and infestations   
Bronchitis * 1  2/171 (1.17%) 
Upper respiratory tract infection * 1  2/171 (1.17%) 
Cystitis * 1  1/171 (0.58%) 
Herpes virus infection * 1  1/171 (0.58%) 
Infection * 1  1/171 (0.58%) 
Influenza * 1  1/171 (0.58%) 
Lung infection * 1  1/171 (0.58%) 
Oral Candidiasis * 1  1/171 (0.58%) 
Skin infection * 1  1/171 (0.58%) 
Vulvovaginal mycotic infection * 1  1/171 (0.58%) 
Investigations   
Platelet count increased * 1  1/171 (0.58%) 
Blood glucose increased * 1  1/171 (0.58%) 
Blood pressure increased * 1  1/171 (0.58%) 
Neutrophil count decreased * 1  1/171 (0.58%) 
Weight decreased * 1  1/171 (0.58%) 
Weight increased * 1  1/171 (0.58%) 
White blood cell count decreased * 1  1/171 (0.58%) 
Metabolism and nutrition disorders   
Hypokalaemia * 1  2/171 (1.17%) 
Hyperkalaemia * 1  1/171 (0.58%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  14/171 (8.19%) 
Bone pain * 1  8/171 (4.68%) 
Musculoskeletal Pain * 1  2/171 (1.17%) 
Pain in extremity * 1  2/171 (1.17%) 
Muscle spasms * 1  1/171 (0.58%) 
Myalgia * 1  1/171 (0.58%) 
Neck pain * 1  1/171 (0.58%) 
Pain in jaw * 1  1/171 (0.58%) 
Nervous system disorders   
Dizziness * 1  4/171 (2.34%) 
Dysgeusia * 1  3/171 (1.75%) 
Headache * 1  2/171 (1.17%) 
Neuropathy peripheral * 1  2/171 (1.17%) 
Dysaesthesia * 1  1/171 (0.58%) 
Polyneuropathy * 1  1/171 (0.58%) 
Syncope * 1  1/171 (0.58%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea exertional * 1  2/171 (1.17%) 
Cough * 1  1/171 (0.58%) 
Epistaxis * 1  1/171 (0.58%) 
Productive cough * 1  1/171 (0.58%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  6/171 (3.51%) 
Nail disorder * 1  3/171 (1.75%) 
Rash * 1  3/171 (1.75%) 
Erythema * 1  2/171 (1.17%) 
Skin disorder * 1  1/171 (0.58%) 
Dermatitis Allergic * 1  1/171 (0.58%) 
Dry skin * 1  1/171 (0.58%) 
Hyperhidrosis * 1  1/171 (0.58%) 
Pruritus * 1  1/171 (0.58%) 
Rash maculo-papular * 1  1/171 (0.58%) 
Vascular disorders   
Axillary vein thrombosis * 1  1/171 (0.58%) 
Hot flush * 1  1/171 (0.58%) 
Hypertension * 1  1/171 (0.58%) 
Jugular vein thrombosis * 1  1/171 (0.58%) 
Subclavian vein thrombosis * 1  1/171 (0.58%) 
1
Term from vocabulary, MedDRA v19.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02956967    
Other Study ID Numbers: ZOB-NIV-1504
C1121004 ( Other Identifier: Alias Study Number )
First Submitted: November 3, 2016
First Posted: November 6, 2016
Results First Submitted: December 11, 2017
Results First Posted: February 11, 2019
Last Update Posted: February 11, 2019