Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002223-42 | EudraCT Number | ||
| CANCER PAIN PH 3 SC STUDY | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether tanezumab is effective in the treatment of cancer pain due to bone metastasis in patients already taking background opioid therapy.
This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group Phase 3 study in cancer subjects requiring treatment with background opioids for pain due to bone metastasis.
Approximately 144 subjects will be randomized to one of 2 treatment groups in a 1:1 ratio (approximately 72 subjects per group). Subjects will receive a total of 3 subcutaneous injections, separated by 8 weeks in addition to background opioids administered throughout the study.
Treatment groups will include: 1. Placebo SC (matching tanezumab SC) in addition to background opioid therapy. 2. Tanezumab 20 mg SC in addition to background opioid therapy.
The study consists of three periods: Pre-Treatment (up to 37 days), Double-Blind Treatment (24 weeks) and Safety Follow-up (24 weeks).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Tanezumab 20 mg subcutaneously |
|
| Arm 2 | Placebo Comparator | Placebo matched to active treatment subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tanezumab | Drug | Subcutaneous study treatment (tanezumab 20 mg or matched placebo) dosed at 8 week intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain) where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 12, 16 and 24 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the each specified week. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Oncologia de Rosario | Rosario | Santa Fe Province | S2000KZE | Argentina | ||
| Monash Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37343145 | Derived | Fallon M, Sopata M, Dragon E, Brown MT, Viktrup L, West CR, Bao W, Agyemang A. A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis. Oncologist. 2023 Dec 11;28(12):e1268-e1278. doi: 10.1093/oncolo/oyad188. |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Total 325 participants signed the inform consent form (ICF). Out of which 158 participants were screen failures, and 11 participants were screened but not enrolled and randomized into the study. Total of 156 participants were enrolled and randomized into the study and assigned to study treatments.
Participants with cancer pain predominantly due to bone metastasis and receiving background opioid therapy, were randomized into 3 treatment arms: tanezumab 20 milligrams (mg), tanezumab 10 mg and placebo. After study start, tanezumab 10 mg arm was discontinued in protocol amendment 3: no new participants were enrolled into the arm. Existing participants in the arm received tanezumab 20 mg for any remaining doses and were included in tanezumab 10/20 mg arm.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to tanezumab subcutaneous (SC) once every 8 weeks for 24 weeks. |
| FG001 | Tanezumab 10 mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2018 | Dec 21, 2022 |
Not provided
Not provided
Not provided
Not provided
| Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24 |
| Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site is assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. The participants describe their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily worst pain intensity was mean of daily worst pain intensity NRS score during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 daily worst pain intensity value was the mean of the daily worst pain intensity NRS scores recorded for each of the 7 days prior to the each specified week. | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Weekly average pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants described their weekly pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly average pain intensity was weekly average pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly average pain intensity value was the weekly average pain intensity NRS scores recorded on any day from the span of 7 days prior to specified week. | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Weekly worst pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants describe their weekly worst pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly worst pain intensity was weekly worst pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly worst pain intensity value was the weekly worst pain intensity NRS scores which was recorded on any day from the span of 7 days prior to specified week. | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Change From Baseline in the Daily Average Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily average pain intensity in the non-index visceral cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants described their pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline is defined as the mean average daily pain intensity NRS score during the baseline assessment period prior to randomization. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily average pain intensity scores for the 7 days prior to the each specified week. | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline pain intensity value was mean of the daily worst pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily worst pain intensity scores for the 7 days prior to the each specified week. | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily average pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of >= 30, 50, 70, and 90 % in daily average pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below. | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily worst pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of >= 30, 50, 70, and 90 % in daily worst pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below. | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition. | Baseline, Weeks 2, 4, 8, 16 and 24 |
| Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores:1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition. | Baseline, Weeks 2, 4, 8, 16 and 24 |
| Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | In this outcome measure average daily opioid consumption was reported in milligram of morphine equivalent dose (mg of MED). | Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | In this outcome measure average number of doses of rescue opioid consumption at specified time points were reported. | Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | OR-SDS: questionnaire evaluated opioid-related 12 symptoms. For each symptom, participants assigned integer scores to assess severity (none =0 to very severe =4), distress (none =0 to very much =5), and frequency (none =0 to almost constantly =4; participants reported number of retching/vomiting episodes (none =0, 1-2 episodes =1, 3-4 episodes =2, 5-6 episodes =3, >6 episodes =4). Frequency composite score: mean of frequency scores from all symptoms, ranged from 0 (none) to 4 (almost constantly); higher scores = worse condition. Severity composite score: mean of severity scores from all 12 symptoms, ranged from 0 (none) to 4 (maximum severity); higher scores = worse condition. Distress composite score: mean of distress scores from all 12 symptoms, ranged from 0 (none) to 5 (maximum distress); higher scores = worse condition. Multi domain average (MDA): average of each symptom for frequency, severity, and distress; ranged from 0 (none) to 4.34 (worse); higher scores = worse condition. | Baseline, Weeks 2, 4, 8, 16, and 24 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (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/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 24 weeks post last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. Participants were followed up to 24 weeks after study drug last dose. | Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48) |
| Number of Participants With Laboratory Abnormalities (Normal Baseline) | Laboratory abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes < 0.8*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; leukocytes<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; total bilirubin>1.5*ULN; activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio >1.1*ULN; bilirubin >1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein; albumin<0.8*LLN, >1.2*ULN; urea nitrogen, creatinine, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; Urine: glucose, ketones, protein, HGB, bilirubin, nitrite >=1. | Baseline (Day 1, before dosing) up to Week 48 |
| Number of Participants With Laboratory Abnormalities (Abnormal Baseline) | Laboratory abnormality criteria included: HGB; hematocrit; erythrocytes < 0.8* LLN; erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; leukocytes <0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; activated partial thromboplastin time, prothrombin time >1.1*ULN; bilirubin>1.5*ULN; aspartate AT, alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein; albumin<0.8*LLN, >1.2*ULN; urea nitrogen, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN. | Baseline (Day 1, before dosing) up to Week 48 |
| Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Change categories for sitting systolic blood pressure measured in millimeter of mercury (mm Hg) were as follows: change <=-40, change >-40 to -30, change >-30 to -20, change >-20 to -10, change >-10 to 0, change >0 to <10, change >=10 to <20, change >=20 to <30, change >=30 to <40 and change >=40. Change categories for sitting diastolic blood pressure measured in mm Hg were as follow: change <=-30, change >-30 to -20, change >-20 to -10, change >-10 to 0, change >0 to <10, change >=10 to <20, change >=20 to <30 and change >=30. Rows with only non-zero data/values, for at least 1 reporting arm, are reported below. | Baseline (Day 1, before dosing) up to Week 24 |
| Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | Electrocardiogram assessment included QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), both had following categories: 450<=Value<480 millisecond (msec), 480<=Value<500 msec and Value>=500 msec. | Baseline (Day 1, before dosing) up to Week 24 |
| Number of Participants With Confirmed Orthostatic Hypotension | Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP >=20 mmHg or reduction in diastolic BP >=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (>) 150 mmHg (mean supine): reduction in systolic BP >=30 mmHg or reduction in diastolic BP >=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. | Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48 |
| Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE | The number of participants with clinically significant findings in weight measurement and were counted as an AE in the study were reported in this outcome measure. | Day 1 of dosing up to maximum of Week 48 |
| Number of Participants With Abnormal Physical Examination at Screening | Physical examination included assessment of general, head, eyes, ears, nose, neck, thyroid, lungs, heart, abdomen, extremities, skin, throat and other. Investigator judged abnormality in physical examinations. | Screening (up to 37 days prior to Day 1) |
| Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Joint-related safety events resulting in total joint replacement and/or discontinuation from the study as well as adverse events were reviewed by the External Adjudication Committee to confirm the potential events as adjudicated join safety event. In this outcome measure, number of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture were reported. Other adjudication outcomes included normal progression of OA and other joint outcome. | During the study, maximum up to Week 48 |
| Number of Participants With At Least 1 Total Joint Replacements (TJR) | Number of participants with joint replacement surgery were reported. | During the study, maximum up to Week 48 |
| Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Number of participants with presence of anti-tanezumab antibodies and neutralizing anti-drug antibodies are reported. | Baseline (Day 1, before dosing) up to Week 48 |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| Monash Medical Centre | East Bentleigh | Victoria | 3165 | Australia |
| Landesklinikum Krems | Krems | 3500 | Austria |
| Nuhr Medical Center | Senftenberg | 3541 | Austria |
| INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Associacao Hospital de Caridade de Ijui | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral | Itajaí | Santa Catarina | 88.301-220 | Brazil |
| Fundação Pio XII-Hospital de Cancer de Barretos | Barretos | São Paulo | 14.784-400 | Brazil |
| Centro de Ensino e Pesquisa da Fundacao Amaral Carvalho | Jaú | São Paulo | 17210-120 | Brazil |
| Fundacao do ABC - Faculdade de Medicina do ABC - CEPHO | Santo André | São Paulo | 09060-650 | Brazil |
| Fundacao do ABC-Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-870 | Brazil |
| Hospital AC Camargo_Fundacao Antonio Prudente | São Paulo | São Paulo | 01509-900 | Brazil |
| Centro de Pesquisa Clinica do IBCC - Instituto Brasileiro de Controle do Cancer | São Paulo | São Paulo | 03102-006 | Brazil |
| Hospital AC Camargo_Fundacao Antonio Prudente | São Paulo | 01509-900 | Brazil |
| James Lind Centro de lnvestigacion del Cancer | Araucania | 4800827 | Chile |
| The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology | Hefei | Anhui | 230022 | China |
| The Fifth Medical Center of PLA General Hospital | Beijing | Beijing Municipality | 100071 | China |
| Daping Hospital, Research Institute of Surgery Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| Harbin Medical University Cancer Hospital/Oncology Department | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital/Respiration internal medicine | Zhengzhou | Henan | 450008 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center | Wuhan | Hubei | 430030 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
| Oncology Department, West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Urocentrum Plzen Research Site s.r.o. | Pilsen | 30100 | Czechia |
| Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Centrum pro lecbu bolesti | Prague | 128 00 | Czechia |
| Veszprem Megyei Tudogyogyintezet Farkasgyepu | Farkasgyepű | 8582 | Hungary |
| CRU Hungary Ltd., MISEK Hematology Department-CRU Co. | Miskolc | 3529 | Hungary |
| CRU Hungary Ltd., MISEK-CRU | Miskolc | 3529 | Hungary |
| Josa Andras Hospital, Clinical Research Department | Nyíregyháza | 4400 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza | 4400 | Hungary |
| Help-MR Diagnosztika Kft. | Székesfehérvár | 8000 | Hungary |
| HaEmek Medical Center | Afula | 1834111 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| National Hospital Organization Toyohashi Medical Center | Toyohashi | Aichi-ken | 440-8510 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| Gunma Prefectural Cancer Center | Ōta | Gunma | 373-8550 | Japan |
| Nishinomiya Municipal Central Hospital | Nishinomiya | Hyōgo | 663-8014 | Japan |
| The Hospital of Hyogo College of Medicine | Nishinomiya | Hyōgo | 663-8501 | Japan |
| Saga-Ken Medical Centre Koseikan | Saga | 840-8571 | Japan |
| National Hospital Organization Tokyo Medical Center | Tokyo | 152-8902 | Japan |
| Powiatowy Zespol Zakladow Opieki Zdrowotnej Oddzial Opieki Paliatywnej | Będzin | 42-500 | Poland |
| NZOZ Vitamed im. Edyty Jakubow | Bialystok | 15-215 | Poland |
| Poradnia Otropedyczno-Urazowa; Gabient RTG | Bialystok | 15-437 | Poland |
| Pracownia RTG Helimed | Czeladź | 41-250 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej, Zespol Medyczno-Opiekunczy Alicja Kluczna | Dąbrowa Górnicza | 41-300 | Poland |
| Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku | Gdansk | 80-208 | Poland |
| Stowarzyszenie Przyjaciol Chorych Hospicjum w Gliwicach NZOZ Hospicjum Milosierdzia Bozego | Gliwice | 44-100 | Poland |
| Stowarzyszenie Przyjaciol Chorych Hospicjum w Gliwicach, NZOZ Hospicjum Milosierdzia Bozego | Gliwice | 44-100 | Poland |
| Regionalny Szpital Specjalistyczny im. Dr. Wl.Bieganskiego, Oddzial Onkologii Klinicznej | Grudziądz | 86-300 | Poland |
| SCANiX Sp.z o.o | Katowice | 40-057 | Poland |
| NZOZ "Vegamed" | Katowice | 40-060 | Poland |
| Helimed Diagnostic Imaging Sp. z o.o., Sp. komandytowa | Katowice | 40-760 | Poland |
| Helimed Diagnostic Imaging Sp. z.o.o., Sp. komandytowa | Katowice | 40-760 | Poland |
| Centrum Diagnostyki Obrazowej EPIONE | Katowice | 40-872 | Poland |
| NZOZ Neuromed M. i M. Nastaj Sp. P. | Lublin | 20-064 | Poland |
| SK Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu, | Poznan | 61-245 | Poland |
| Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej w Centrum Onkologii -Instytucie | Warsaw | 02-781 | Poland |
| Szpital LUX MED | Warsaw | 02-801 | Poland |
| SC Oncolab SRL | Craiova | Dolj | 200385 | Romania |
| S.C. Oncocenter Oncologie Clinica S.R.L. | Timișoara | Timiș County | 300166 | Romania |
| Spitalul Clinic C.F. 2 Bucuresti. Departament Oncologie, Sectia Medicala 2 | Bucharest | 011464 | Romania |
| Narodny onkologicky ustav | Bratislava | 833 10 | Slovakia |
| DEMOMED s.r.o. | Nové Zámky | 94001 | Slovakia |
| MUDr. Viliam Cibik, PhD, s.r.o. | Pruské | 018 52 | Slovakia |
| Fakultna Nemocnica S Poliklinikou Zilina | Žilina | 012 07 | Slovakia |
| Clinical Trial Pharmacy, National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Imaging Facilities, National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 42601 | South Korea |
| Clinical Trial Pharmacy, Severance Hospital | Seoul | 03722 | South Korea |
| Imaging Facilities, Severance Hospital | Seoul | 03722 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital General Universitario de Elche Servicio de Farmacia | Elche | Alicante | 03203 | Spain |
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain |
| Hospital Can Misses | Ibiza Town | Balearic Islands | 07800 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital La Moraleja | Madrid | 28050 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| St George's University Hospitals NHS Foundation Trust | Tooting | London | SW17 0QT | United Kingdom |
| NHS Lothian, Royal Infirmary of Edinburgh | Edinburgh | Scotland | EH16 4SA | United Kingdom |
| NHS Lothian, Western General Hospital | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| NHS Lothian | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| FG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| FG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety analysis set included all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks. |
| BG001 | Tanezumab 10 mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| BG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| BG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8. | The modified intent to treat (mITT) analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Week 8 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 12, 16 and 24 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain) where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 12, 16 and 24 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the each specified week. | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site is assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. The participants describe their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline daily worst pain intensity was mean of daily worst pain intensity NRS score during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 daily worst pain intensity value was the mean of the daily worst pain intensity NRS scores recorded for each of the 7 days prior to the each specified week. | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Average Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Weekly average pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants described their weekly pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly average pain intensity was weekly average pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly average pain intensity value was the weekly average pain intensity NRS scores recorded on any day from the span of 7 days prior to specified week. | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Worst Pain Intensity NRS Score in Non-Index Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Weekly worst pain intensity in the non-index cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), higher scores signified more severity of pain. Non-index cancer pan sites were the most painful cancer pain sites other than the index bone metastasis cancer pain site. The participants describe their weekly worst pain at the painful site by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline weekly worst pain intensity was weekly worst pain intensity NRS score recorded on any day during the baseline assessment period. Five days prior to dosing was considered as baseline assessment period. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 weekly worst pain intensity value was the weekly worst pain intensity NRS scores which was recorded on any day from the span of 7 days prior to specified week. | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Daily Average Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily average pain intensity in the non-index visceral cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants described their pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline is defined as the mean average daily pain intensity NRS score during the baseline assessment period prior to randomization. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily average pain intensity scores for the 7 days prior to the each specified week. | Participant with non-index visceral cancer pain sites were less than 10, hence data was not collected and analysis was not performed for this outcome measure. | Posted | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Daily Worst Pain Intensity NRS Score in the Non-Index Visceral Cancer Pain Sites at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. Baseline pain intensity value was mean of the daily worst pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value is the mean of the daily worst pain intensity scores for the 7 days prior to the each specified week. | Participant with non-index visceral cancer pain sites were less than 10, hence data was not collected and analysis was not performed for this outcome measure. | Posted | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cumulative Reduction of >=30, 50, 70 and 90 Percent (%) From Baseline in Daily Average Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily average pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of >= 30, 50, 70, and 90 % in daily average pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below. | The mITT analysis set was analyzed. Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation Carried Forward (LOCF) imputation was applied. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Count of Participants | Participants | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reduction of >=30, 50, 70 and 90% From Baseline in Daily Worst Pain Intensity NRS Score in the Index Bone Metastasis Cancer Pain Site at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | Daily worst pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores = more severity of pain. The participants recorded their daily worst pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on IRT diaries. The Weeks 1, 2, 4, 6, 8, 12, 16 and 24 pain intensity value = mean of the daily worst pain intensity NRS scores for the 7 days prior to the each week. Number of participants with cumulative reduction of >= 30, 50, 70, and 90 % in daily worst pain intensity NRS score in the index bone metastasis cancer pain site from Baseline to Weeks 1, 2, 4, 6, 8, 12, 16 and 24 were reported. Participants might be reported more than once in the specified rows for a time point. Rows with only non-zero data for cumulative reduction at specified time points, for at least 1 reporting arm, are reported below. | The mITT analysis set was analyzed. Multiple imputation method was applied. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Count of Participants | Participants | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Participant's Global Assessment of Cancer Pain (PGA-CP) at Weeks 2, 4, 8, 16 and 24 | Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores: 1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition. | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Weeks 2, 4, 8, 16 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Reduction of >=2 Points From Baseline in PGA-CP Scores at Weeks 2, 4, 8, 16 and 24 | Participants at specified time points, answered to the following question, "Considering all the ways your cancer pain affects you, how are you doing today?" on a Likert scale ranging from 1 to 5, on IRT diaries. Scores:1= very good (asymptomatic and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores signified worsening of condition. | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. Here, ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Count of Participants | Participants | Baseline, Weeks 2, 4, 8, 16 and 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Daily Total Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | In this outcome measure average daily opioid consumption was reported in milligram of morphine equivalent dose (mg of MED). | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. LOCF data was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Mean | Standard Deviation | mg of MED | Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Number of Doses of Rescue Opioid Consumption at Weeks 1, 2, 4, 6, 8, 12, 16 and 24 | In this outcome measure average number of doses of rescue opioid consumption at specified time points were reported. | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. LOCF data was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Doses | Weeks 1, 2, 4, 6, 8, 12, 16 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Opioid-Related Symptom Distress Scale (OR-SDS) at Weeks 2, 4, 8, 16, and 24 | OR-SDS: questionnaire evaluated opioid-related 12 symptoms. For each symptom, participants assigned integer scores to assess severity (none =0 to very severe =4), distress (none =0 to very much =5), and frequency (none =0 to almost constantly =4; participants reported number of retching/vomiting episodes (none =0, 1-2 episodes =1, 3-4 episodes =2, 5-6 episodes =3, >6 episodes =4). Frequency composite score: mean of frequency scores from all symptoms, ranged from 0 (none) to 4 (almost constantly); higher scores = worse condition. Severity composite score: mean of severity scores from all 12 symptoms, ranged from 0 (none) to 4 (maximum severity); higher scores = worse condition. Distress composite score: mean of distress scores from all 12 symptoms, ranged from 0 (none) to 5 (maximum distress); higher scores = worse condition. Multi domain average (MDA): average of each symptom for frequency, severity, and distress; ranged from 0 (none) to 4.34 (worse); higher scores = worse condition. | The mITT analysis set: participants randomized to tanezumab 20 mg or placebo SC, received at least 1dose of SC study medication. Multiple imputation method was applied. As planned summarized efficacy data for tanezumab 10 mg and 10/20 mg arms not reported; for these 2 arms individual values are reported. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and ''number analyzed'' signifies participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Weeks 2, 4, 8, 16, and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (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/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 24 weeks post last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs. Participants were followed up to 24 weeks after study drug last dose. | The safety analysis set was defined as all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3. | Posted | Count of Participants | Participants | Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities (Normal Baseline) | Laboratory abnormality criteria included: hemoglobin (HGB); hematocrit; erythrocytes < 0.8*lower limit of normal (LLN); erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; leukocytes<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; total bilirubin>1.5*ULN; activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio >1.1*ULN; bilirubin >1.5*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein; albumin<0.8*LLN, >1.2*ULN; urea nitrogen, creatinine, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; Urine: glucose, ketones, protein, HGB, bilirubin, nitrite >=1. | The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants with a normal baseline with at least one observation of the given laboratory test while on the study. There were no participants in reporting arm "Tanezumab10/20 mg", who met the criteria for data collection and analysis of this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1, before dosing) up to Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities (Abnormal Baseline) | Laboratory abnormality criteria included: HGB; hematocrit; erythrocytes < 0.8* LLN; erythrocyte mean corpuscular volume/HGB/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*upper limit of normal (ULN); platelets <0.5*LLN,>1.75* ULN; leukocytes <0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; activated partial thromboplastin time, prothrombin time >1.1*ULN; bilirubin>1.5*ULN; aspartate AT, alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase >3.0*ULN; protein; albumin<0.8*LLN, >1.2*ULN; urea nitrogen, cholesterol, triglycerides >1.3*ULN; urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN. | The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants with an abnormal baseline with at least one observation of the given laboratory test while on the study. There were no participants in reporting arm "Tanezumab10/20 mg", who met the criteria for data collection and analysis of this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1, before dosing) up to Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Categorical Change From Baseline to Last Post-Baseline in Sitting Systolic and Diastolic Blood Pressure During Treatment Period | Change categories for sitting systolic blood pressure measured in millimeter of mercury (mm Hg) were as follows: change <=-40, change >-40 to -30, change >-30 to -20, change >-20 to -10, change >-10 to 0, change >0 to <10, change >=10 to <20, change >=20 to <30, change >=30 to <40 and change >=40. Change categories for sitting diastolic blood pressure measured in mm Hg were as follow: change <=-30, change >-30 to -20, change >-20 to -10, change >-10 to 0, change >0 to <10, change >=10 to <20, change >=20 to <30 and change >=30. Rows with only non-zero data/values, for at least 1 reporting arm, are reported below. | The safety analysis set was defined as all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1, before dosing) up to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Categorical Summary of Electrocardiogram (ECG) (QTC) Data | Electrocardiogram assessment included QT interval corrected using Fridericia's formula (QTcF), QT interval corrected using Bazett's formula (QTcB), both had following categories: 450<=Value<480 millisecond (msec), 480<=Value<500 msec and Value>=500 msec. | The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants with post-baseline results evaluated against criteria. In reporting arm "Tanezumab10/20 mg", the participant did not have post-baseline results evaluated against ECG (QTC) criteria, hence was not evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (Day 1, before dosing) up to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Confirmed Orthostatic Hypotension | Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: for systolic blood pressure (BP) less than or equal to (<=) 150 millimeter of mercury (mmHg) (mean supine): reduction in systolic BP >=20 mmHg or reduction in diastolic BP >=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP greater than (>) 150 mmHg (mean supine): reduction in systolic BP >=30 mmHg or reduction in diastolic BP >=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. | The safety analysis set included all subjects treated with tanezumab or placebo SC, including subjects who received tanezumab 10 mg prior to protocol amendment 3. Here, "number analyzed" signifies participants evaluable at specific time points. | Posted | Count of Participants | Participants | Baseline (Day 1, before dosing), Weeks 8, 16, 24 and 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Findings in Weight Measurement, Counted as an AE | The number of participants with clinically significant findings in weight measurement and were counted as an AE in the study were reported in this outcome measure. | The safety analysis set included all subjects treated with tanezumab or placebo SC, including subjects who received tanezumab 10 mg prior to protocol amendment 3. | Posted | Count of Participants | Participants | Day 1 of dosing up to maximum of Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Physical Examination at Screening | Physical examination included assessment of general, head, eyes, ears, nose, neck, thyroid, lungs, heart, abdomen, extremities, skin, throat and other. Investigator judged abnormality in physical examinations. | The safety analysis set included all subjects treated with tanezumab or placebo SC, including subjects who received tanezumab 10 mg prior to protocol amendment 3. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable at specific time points. | Posted | Count of Participants | Participants | Screening (up to 37 days prior to Day 1) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Individual Adjudicated Joint Safety Outcome/Event | Joint-related safety events resulting in total joint replacement and/or discontinuation from the study as well as adverse events were reviewed by the External Adjudication Committee to confirm the potential events as adjudicated join safety event. In this outcome measure, number of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture were reported. Other adjudication outcomes included normal progression of OA and other joint outcome. | The safety analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants who were analyzed by the Adjudication Committee. In reporting arm, "Tanezumab10/20 mg" the participant did not have potential joint related safety event for analysis by Adjudication Committee. | Posted | Count of Participants | Participants | During the study, maximum up to Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With At Least 1 Total Joint Replacements (TJR) | Number of participants with joint replacement surgery were reported. | The safety analysis set included all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3. | Posted | Count of Participants | Participants | During the study, maximum up to Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Anti-Drug Antibodies (NAb) | Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Number of participants with presence of anti-tanezumab antibodies and neutralizing anti-drug antibodies are reported. | The safety analysis set included all participants treated with tanezumab or placebo SC, including participants who received tanezumab 10 mg prior to protocol amendment 3. | Posted | Count of Participants | Participants | Baseline (Day 1, before dosing) up to Week 48 |
|
Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set was evaluated.
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 | Placebo | Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks. | 23 | 73 | 52 | 73 | 43 | 73 |
| EG001 | Tanezumab 10 mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. | 1 | 9 | 9 | 9 | 8 | 9 |
| EG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. | 21 | 72 | 62 | 72 | 49 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gingival swelling | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Application site reaction | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Allergy to plants | Immune system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Carbohydrate antigen 15-3 increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Carcinoembryonic antigen increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Haematology test abnormal | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma antigen | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypocholesterolaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Mineral deficiency | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Thoracic spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vertebral osteophyte | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Metastases to ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Paraneoplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Sacral radiculopathy | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hyposomnia | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Micturition disorder | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Breast disorder | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Skin oedema | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vascular fragility | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA v24.0 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2021 | Dec 21, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549319 | tanezumab |
Not provided
Not provided
Not provided
| >=45 to <65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Tanezumab 10 mg |
Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
| Tanezumab 10 mg |
Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
| OG001 | Tanezumab 10 mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
| OG001 | Tanezumab 10 mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG003 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
|
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
| OG001 | Tanezumab 10 mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
| OG001 | Tanezumab 10 mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
| OG001 | Tanezumab 10mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
|
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| OG001 | Tanezumab 10 mg | Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment. |
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| Tanezumab 20 mg |
Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| OG002 | Tanezumab 10/20 mg | Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks. |
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| OG003 | Tanezumab 20 mg | Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|