TriangleNCT00128102 · STUDY IN CONTEXT
Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014)
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. 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
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of final analysis were censored at the date of the last follow up. The final analysis for OS was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. OS analysis is reported here for all randomized participants.
An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. Reporting of AEs per NCI CTCAE is based on 5 grades of severity; Grade 1 (mild; no treatment needed), Grade 2 (moderate; minimal treatment needed), Grade 3 (severe, not life threatening; hospitalization needed), Grade 4 (life threatening; urgent treatment needed) and Grade 5 (death).The final analysis for Grade 3 or 4 AEs was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced Grade 3/4 AEs per NCI CTCAE is reported here for all randomized participants who received ≥1 dose of study treatment.
An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who experienced an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced an AE is reported here for all randomized participants who received ≥1 dose of study treatment.
An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who discontinued study treatment due to an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who discontinued study treatment due to an AE is reported here for all randomized participants who received ≥1 dose of study treatment. As specified by the protocol, participants who discontinued study treatment due to an AE remained on study until investigator notification to discontinue.
PFS was defined as the time from randomization to the first documented progressive disease (PD) per meso-modified-Response Evaluation Criteria in Solid Tumors (Meso-modified RECIST) based on independent radiology review or death due to any cause, whichever occurred first. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. Per meso-modified RECIST, PD was defined as ≥20% increase in the total tumor measurement over the nadir measurement or the appearance of ≥1 new lesions. The final analysis for PFS per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. PFS analysis per Meso-modified RECIST by independent radiology review is reported here for all randomized participants.
ORR was defined as the percentage of participants in the analysis population who had a complete response (CR: disappearance of all target lesions with no evidence of tumor elsewhere) or a partial response (PR: ≥30% reduction in the total tumor measurement) per Meso-modified RECIST based on independent radiology review. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. The final analysis for ORR per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol percentage of participants who had a CR or a PR per Meso-modified RECIST by independent radiology review is reported here as the ORR for all randomized participants who had valid baseline data for ORR analysis available.
Reported safety
Quality of life and patient-reported measures
Unnamed quality-of-life measure · Percent Change From Baseline in Lung Cancer Symptom Scale, Modified for Mesothelioma (LCSS-Meso) Dyspnea Score at Week 12
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- qol key
- qol-0006
- source section id
- NCT00128102-om-0006
- source outcome index
- 6
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Percent Change From Baseline in Lung Cancer Symptom Scale, Modified for Mesothelioma (LCSS-Meso) Dyspnea Score at Week 12
- measure definition
- LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percent change in the LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100)\] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- time frame
- Baseline, Week 12
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- Higher scores indicate dyspnea worse
- population note
- All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- qol key
- qol-0007
- source section id
- NCT00128102-om-0007
- source outcome index
- 7
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12
- measure definition
- LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥50% change (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100) and \>10 mm absolute change in LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- time frame
- Baseline, Week 12
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- Higher scores indicate dyspnea worse
- population note
- All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- trial label
- Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) Versus Placebo in Advanced Malignant Pleural Mesothelioma (MK-0683-014)
- 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.
- 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
- 2
- qol Count
- 2
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0000
- source section id
- NCT00128102-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of final analysis were censored at the date of the last follow up. The final analysis for OS was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. OS analysis is reported here for all randomized participants.
- time origin
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants randomized to a study arm.
- 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-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0001
- source section id
- NCT00128102-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants Who Experienced Adverse Events (AEs) Characterized as Grade 3 or Grade 4 According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
- endpoint definition
- An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. Reporting of AEs per NCI CTCAE is based on 5 grades of severity; Grade 1 (mild; no treatment needed), Grade 2 (moderate; minimal treatment needed), Grade 3 (severe, not life threatening; hospitalization needed), Grade 4 (life threatening; urgent treatment needed) and Grade 5 (death).The final analysis for Grade 3 or 4 AEs was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced Grade 3/4 AEs per NCI CTCAE is reported here for all randomized participants who received ≥1 dose of study treatment.
- time origin
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants randomized to a study arm who received ≥1 dose of study treatment.
- 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-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0002
- source section id
- NCT00128102-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants Who Experienced an AE
- endpoint definition
- An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who experienced an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced an AE is reported here for all randomized participants who received ≥1 dose of study treatment.
- time origin
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants randomized to a study arm who received ≥1 dose of study treatment.
- 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-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0003
- source section id
- NCT00128102-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants Who Discontinued Study Treatment Due to an AE
- endpoint definition
- An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who discontinued study treatment due to an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who discontinued study treatment due to an AE is reported here for all randomized participants who received ≥1 dose of study treatment. As specified by the protocol, participants who discontinued study treatment due to an AE remained on study until investigator notification to discontinue.
- time origin
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants randomized to a study arm who received ≥1 dose of study treatment.
- 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-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0004
- source section id
- NCT00128102-om-0004
- source outcome index
- 4
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- PFS was defined as the time from randomization to the first documented progressive disease (PD) per meso-modified-Response Evaluation Criteria in Solid Tumors (Meso-modified RECIST) based on independent radiology review or death due to any cause, whichever occurred first. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. Per meso-modified RECIST, PD was defined as ≥20% increase in the total tumor measurement over the nadir measurement or the appearance of ≥1 new lesions. The final analysis for PFS per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. PFS analysis per Meso-modified RECIST by independent radiology review is reported here for all randomized participants.
- time origin
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants randomized to a study arm.
- 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-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0005
- source section id
- NCT00128102-om-0005
- source outcome index
- 5
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- ORR was defined as the percentage of participants in the analysis population who had a complete response (CR: disappearance of all target lesions with no evidence of tumor elsewhere) or a partial response (PR: ≥30% reduction in the total tumor measurement) per Meso-modified RECIST based on independent radiology review. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. The final analysis for ORR per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol percentage of participants who had a CR or a PR per Meso-modified RECIST by independent radiology review is reported here as the ORR for all randomized participants who had valid baseline data for ORR analysis available.
- time origin
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants randomized to a study arm who had valid baseline data for ORR analysis available.
- 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-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Vorinostat
- regimen
- Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 329
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 332
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Vorinostat
- regimen
- Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 329
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 329
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Vorinostat
- regimen
- Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 329
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 329
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Vorinostat
- regimen
- Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 329
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 329
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Vorinostat
- regimen
- Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 329
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 332
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Vorinostat
- regimen
- Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 318
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- analyzed count
- 323
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00128102-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- harm key
- EG000
- source section id
- NCT00128102-ae
- event group key
- EG000
- event group label
- Vorinostat
- serious affected
- 133
- serious at risk
- 329
- other affected
- 303
- other at risk
- 329
- frequency threshold
- 5
- collection period
- Up to ~77 months (through database cut-off date of 21-November-2011)
- event definition
- All-Cause Mortality table includes all randomized participants. Serious AEs and other AEs tables include all randomized participants who got ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Thus Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
- 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-lung-neoplasm
- nct id
- NCT00128102
- harm key
- EG001
- source section id
- NCT00128102-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 131
- serious at risk
- 329
- other affected
- 281
- other at risk
- 329
- frequency threshold
- 5
- collection period
- Up to ~77 months (through database cut-off date of 21-November-2011)
- event definition
- All-Cause Mortality table includes all randomized participants. Serious AEs and other AEs tables include all randomized participants who got ≥1 dose of study drug. Per protocol disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Thus Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT00128102
- qol key
- qol-0006
- source section id
- NCT00128102-om-0006
- source outcome index
- 6
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Percent Change From Baseline in Lung Cancer Symptom Scale, Modified for Mesothelioma (LCSS-Meso) Dyspnea Score at Week 12
- measure definition
- LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percent change in the LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100)\] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- time frame
- Baseline, Week 12
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- Higher scores indicate dyspnea worse
- population note
- All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- 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-lung-neoplasm
- nct id
- NCT00128102
- qol key
- qol-0007
- source section id
- NCT00128102-om-0007
- source outcome index
- 7
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12
- measure definition
- LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥50% change (percent change calculated: \[Week 12 - Baseline\]/Baseline\*100) and \>10 mm absolute change in LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- time frame
- Baseline, Week 12
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- Higher scores indicate dyspnea worse
- population note
- All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice