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| ID | Type | Description | Link |
|---|---|---|---|
| C1121004 | Other Identifier | Alias Study Number |
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Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Nivestim |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overall satisfaction questionnaires of home use of Nivestim | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Any Significant Comorbidities | 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. | Baseline (Day 1) |
| Percentage of Participants With Different Types of Haematological Malignancies | 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. | Baseline (Day 1) |
| Percentage of Participants With Different Types of Solid Tumour | 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. | Baseline (Day 1) |
| Duration of Solid Tumour in Participants Prior to Enrolment in Study | 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. | Baseline (Day 1) |
| Number of Participants Who Received Chemotherapy Prior to Enrolment in Study | Baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants' Overall Satisfaction Scores in Response to the Study Treatment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Adults undergoing cytotoxic chemotherapy treated prophylactically with NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced FN.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Manfred Welslau | Aschaffenburg | 63739 | Germany | |||
| Office of Martine Klausmann |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30410313 | Derived | Otremba B, Hielscher C, Petersen V, Petrik C. Home administration of filgrastim (Nivestim) in primary prophylaxis of chemotherapy-induced febrile neutropenia. Patient Prefer Adherence. 2018 Oct 16;12:2179-2186. doi: 10.2147/PPA.S168029. eCollection 2018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Duration of Different Types of Chemotherapies Received by Participants During Study | Baseline up to 6 months |
| Percentage of Participants With Response to Study Treatment | Baseline up to 6 months |
| Baseline up to 6 months |
| Participant's Assessment for Nivestim Packaging | 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. | Baseline up to 6 months |
| Participant's Assessment of Injection Site Pain and Tolerability | 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. | Baseline up to 6 months |
| Participant's Assessment of Overall Tolerability of Subcutaneous Injection | 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. | Baseline up to 6 months |
| Percentage of Participants With Neutropenia | Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9 Neutrophils per Liter were reported in this outcome measure. | Baseline up to 6 months |
| Percentage of Participants With at Least One Infection and Serious Infection | 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. | Baseline up to 6 months |
| Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | Baseline, Cycle 1, 2, 3, 4, 5, 6 |
| Minimum Value of Absolute Neutrophil Count | Cycle 1, 2, 3, 4, 5, 6 |
| Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle | End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6) |
| Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | Cycle 1, 2, 3, 4, 5, 6 |
| Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count | Cycle 1, 2, 3, 4, 5, 6 |
| Percentage of Participants With Febrile Neutropenia | 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. | Baseline up to 6 months |
| Baseline up to 6 months |
| Aschaffenburg |
| 63739 |
| Germany |
| Office of Bernhard Heinrich | Augsburg | 86150 | Germany |
| Campus Charite Mitte, Med. Klinik m. Schwerpunkt Haematologie und Onkologie | Berlin | 10117 | Germany |
| Office of Reinhard Musch | Berlin | 13055 | Germany |
| Office of Peter Klare | Berlin | 13595 | Germany |
| Office of Ute Bückner | Bochum | 44787 | Germany |
| Office of Peter Jungberg | Chemnitz | 09117 | Germany |
| Office of Ivo Azeh | Gelsenkirchen | 45879 | Germany |
| Office of Peter von Wussow | Hanover | 30449 | Germany |
| Office of Volker Petersen | Heidenheim | 89518 | Germany |
| Office of Lars-Jörgen Hahn | Herne | 44623 | Germany |
| Office of Michael Neise | Krefeld | 47804 | Germany |
| Office of Gunther Rogmans | Krefeld | 47805 | Germany |
| Office of Peter Anhut | Kronach | 96317 | Germany |
| Office of Albrecht Kretzschmar | Leipzig | 04103 | Germany |
| Office of Nidal Gazawi | Leipzig | 04107 | Germany |
| Office of Udo Hieber | Mannheim | 68165 | Germany |
| Office of Christoph Salat | München | 80638 | Germany |
| Office of Christian Lerchenmüller | Münster | 48149 | Germany |
| Office of Burkhard Otremba | Oldenburg | 26121 | Germany |
| Office of Julian Topaly | Osnabrück | 49076 | Germany |
| Office of Andre-Robert Rotmann | Rodgau | 63110 | Germany |
| Office of Rene Schubert | Scheibenberg | 09481 | Germany |
| Office of Matthias Groschek | Stolberg | 52222 | Germany |
| Office of Carsten Hielscher | Stralsund | 18435 | Germany |
| Office of Thomas Kuhn | Stuttgart | 70193 | Germany |
| Office of Ortwin Klein | Wiesbaden | 65191 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set included all participants with at least one dose of Nivestim documented in electronic case report form (eCRF).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Any Significant Comorbidities | 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. | Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. | Posted | Number | percentage of participants | Baseline (Day 1) |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Different Types of Haematological Malignancies | 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. | Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. | Posted | Number | percentage of participants | Baseline (Day 1) |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Different Types of Solid Tumour | 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. | Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. | Posted | Number | percentage of participants | Baseline (Day 1) |
|
| |||||||||||||||||||||||||||
| Primary | Duration of Solid Tumour in Participants Prior to Enrolment in Study | 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. | 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. | Posted | Mean | Standard Deviation | years | Baseline (Day 1) |
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants Who Received Chemotherapy Prior to Enrolment in Study | Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. | Posted | Number | participants | Baseline (Day 1) |
|
| ||||||||||||||||||||||||||||
| Primary | Duration of Different Types of Chemotherapies Received by Participants During Study | The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol. | Posted | Baseline up to 6 months |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Response to Study Treatment | The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol. | Posted | Baseline up to 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Participants' Overall Satisfaction Scores in Response to the Study Treatment | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline up to 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Participant's Assessment for Nivestim Packaging | 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. | 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. | Posted | Number | participants | Baseline up to 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Participant's Assessment of Injection Site Pain and Tolerability | 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. | 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. | Posted | Number | participants | Baseline up to 6 months |
| ||||||||||||||||||||||||||||
| Secondary | Participant's Assessment of Overall Tolerability of Subcutaneous Injection | 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. | 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. | Posted | Number | participants | Baseline up to 6 months |
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Neutropenia | Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9 Neutrophils per Liter were reported in this outcome measure. | Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. | Posted | Number | percentage of participants | Baseline up to 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Infection and Serious Infection | 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. | Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. | Posted | Number | percentage of participants | Baseline up to 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6 | 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. | Posted | Mean | Standard Deviation | 10^9 Neutrophils per Liter | Baseline, Cycle 1, 2, 3, 4, 5, 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Minimum Value of Absolute Neutrophil Count | 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. | Posted | Mean | Standard Deviation | 10^9 Neutrophils per Liter | Cycle 1, 2, 3, 4, 5, 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle | 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. | Posted | Mean | Standard Deviation | 10^9 Neutrophils per Liter | End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6) |
|
| |||||||||||||||||||||||||||
| Secondary | Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count | 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. | Posted | Mean | Standard Deviation | 10^9 Neutrophils per Liter | Cycle 1, 2, 3, 4, 5, 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count | 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. | Posted | Median | Full Range | days | Cycle 1, 2, 3, 4, 5, 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Febrile Neutropenia | 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. | Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. | Posted | Number | percentage of participants | Baseline up to 6 months |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. | Posted | Count of Participants | Participants | Baseline up to 6 months |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. | 0 | 171 | 16 | 171 | 74 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Mucosal toxicity | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v19.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v19.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v19.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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