TriangleNCT02609828 · STUDY IN CONTEXT
Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- trial label
- Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0000
- source section id
- NCT02609828-om-0000
- source outcome index
- 0
- endpoint
- Change From Baseline in the Daily Average Pain Intensity Numerical Rating Score (NRS) in the Index Bone Metastasis Cancer Pain Site at Week 8
- endpoint definition
- 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.
- time origin
- Baseline, Week 8
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0001
- source section id
- NCT02609828-om-0001
- source outcome index
- 1
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- Baseline, Weeks 1, 2, 4, 6, 12, 16 and 24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0002
- source section id
- NCT02609828-om-0002
- source outcome index
- 2
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0003
- source section id
- NCT02609828-om-0003
- source outcome index
- 3
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0004
- source section id
- NCT02609828-om-0004
- source outcome index
- 4
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0005
- source section id
- NCT02609828-om-0005
- source outcome index
- 5
- endpoint
- 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
- endpoint definition
- 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.
- time origin
- Baseline, Weeks 1, 2, 4, 6, 8, 12, 16 and 24
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Tanezumab 10 mg
- regimen
- 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.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Tanezumab 10/20 mg
- regimen
- 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.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Tanezumab 20 mg
- regimen
- Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Tanezumab 10 mg
- regimen
- 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.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Tanezumab 10/20 mg
- regimen
- 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.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Tanezumab 20 mg
- regimen
- Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Placebo
- regimen
- Participants received placebo matched to tanezumab SC once every 8 weeks for 24 weeks.
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Tanezumab 10 mg
- regimen
- 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.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Tanezumab 10/20 mg
- regimen
- 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.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Tanezumab 20 mg
- regimen
- Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02609828-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- harm key
- EG000
- source section id
- NCT02609828-ae
- event group key
- EG000
- event group label
- Placebo
- serious affected
- 52
- serious at risk
- 73
- other affected
- 43
- other at risk
- 73
- frequency threshold
- 2
- collection period
- Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- harm key
- EG001
- source section id
- NCT02609828-ae
- event group key
- EG001
- event group label
- Tanezumab 10 mg
- serious affected
- 9
- serious at risk
- 9
- other affected
- 8
- other at risk
- 9
- frequency threshold
- 2
- collection period
- Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- harm key
- EG002
- source section id
- NCT02609828-ae
- event group key
- EG002
- event group label
- Tanezumab 10/20 mg
- serious affected
- 1
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 2
- collection period
- Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-bone-neoplasm
- nct id
- NCT02609828
- harm key
- EG003
- source section id
- NCT02609828-ae
- event group key
- EG003
- event group label
- Tanezumab 20 mg
- serious affected
- 62
- serious at risk
- 72
- other affected
- 49
- other at risk
- 72
- frequency threshold
- 2
- collection period
- Day 1 of dosing up to 24 weeks post last dose (maximum up to Week 48)
- event definition
- 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.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice