TriangleNCT03261947 · STUDY IN CONTEXT
A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumo
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
DLT:Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events(CTCAE) version4.03;Non-febrile Grade 4 neutropenia; febrile neutropenia: Grade \>=3 neutropenia; Grade4 thrombocytopenia; Grade \>=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in initiation of Cycle 2 by \>14 days due to lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by echocardiogram(ECHO) or multiple gated acquisition(MUGA) scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by investigator to be related to study drug and dose-limiting; Participants receiving \<50% of doses (\<7 doses) of planned TAK-931 dosing in Cycle 1 due to study drug-related adverse events(AEs); Grade \>=3 nonhematologic toxicity with few exceptions: Grade 3 arthralgia/myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria.
DCR was defined as percentage of participants documented to have unconfirmed CR, PR, or SD for at least 6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as the best response. CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Cmax: Maximum Observed Plasma Concentration for TAK-931
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931
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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- trial label
- A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumo
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0000
- source section id
- NCT03261947-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Dose Limiting Toxicities (DLTs) in Western Safety Cohort
- endpoint definition
- DLT:Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events(CTCAE) version4.03;Non-febrile Grade 4 neutropenia; febrile neutropenia: Grade \>=3 neutropenia; Grade4 thrombocytopenia; Grade \>=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in initiation of Cycle 2 by \>14 days due to lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by echocardiogram(ECHO) or multiple gated acquisition(MUGA) scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by investigator to be related to study drug and dose-limiting; Participants receiving \<50% of doses (\<7 doses) of planned TAK-931 dosing in Cycle 1 due to study drug-related adverse events(AEs); Grade \>=3 nonhematologic toxicity with few exceptions: Grade 3 arthralgia/myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea.
- time origin
- Cycle 1 (each cycle = 21 days)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- DLT-evaluable Analysis Set included all participants in the Western Safety Cohort who received at least 1 of their planned TAK-931 doses during their first cycle of treatment (unless interrupted by related AEs) and who had sufficient follow-up data to allow the investigators and sponsor to determine whether a DLT occurred. As pre-specified in the protocol, DLTs were collected only from participants in the Western Safety Cohort who were evaluable in DLT-evaluable Analysis Set.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0001
- source section id
- NCT03261947-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort
- endpoint definition
- An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria.
- time origin
- From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure reports data only in the participants with locally advanced or metastatic solid tumors in the Western Safety Cohort.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0002
- source section id
- NCT03261947-om-0002
- source outcome index
- 2
- endpoint
- Disease Control Rate (DCR) in Tumor-Specific Cohorts
- endpoint definition
- DCR was defined as percentage of participants documented to have unconfirmed CR, PR, or SD for at least 6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as the best response. CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- time origin
- From first dose up to end of treatment (Up to approximately 14 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Response-evaluable Analysis Set included all participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline response assessment. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0003
- source section id
- NCT03261947-om-0003
- source outcome index
- 3
- endpoint
- Cmax: Maximum Observed Plasma Concentration for TAK-931
- endpoint definition
- Cmax: Maximum Observed Plasma Concentration for TAK-931
- time origin
- Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Pharmacokinetic (PK) Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0004
- source section id
- NCT03261947-om-0004
- source outcome index
- 4
- endpoint
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931
- endpoint definition
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931
- time origin
- Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0005
- source section id
- NCT03261947-om-0005
- source outcome index
- 5
- endpoint
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931
- endpoint definition
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931
- time origin
- Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Western Safety Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Western Safety Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Pancreatic Cancer Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Metastatic CRC Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0002
- arm key
- OG002
- arm label
- sqEC Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0002
- arm key
- OG003
- arm label
- sqNSCLC Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Western Safety Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Pancreatic Cancer Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Metastatic CRC Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Western Safety Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Pancreatic Cancer Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- outcome key
- om-0004
- arm key
- OG002
- arm label
- Metastatic CRC Cohort
- regimen
- TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03261947-om-0004#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- harm key
- EG000
- source section id
- NCT03261947-ae
- event group key
- EG000
- event group label
- Western Safety Cohort
- serious affected
- 7
- serious at risk
- 12
- other affected
- 5
- other at risk
- 12
- frequency threshold
- 5
- collection period
- All-Cause Mortality: Up to approximately 43 months; Serious and Other Adverse Events: From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
- event definition
- At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. A total of 67 deaths occurred in this study. Since all the information for death data could not be collected, not all deaths could be reported in all-cause mortality.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- harm key
- EG001
- source section id
- NCT03261947-ae
- event group key
- EG001
- event group label
- Pancreatic Cancer Cohort
- serious affected
- 6
- serious at risk
- 15
- other affected
- 8
- other at risk
- 15
- frequency threshold
- 5
- collection period
- All-Cause Mortality: Up to approximately 43 months; Serious and Other Adverse Events: From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
- event definition
- At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. A total of 67 deaths occurred in this study. Since all the information for death data could not be collected, not all deaths could be reported in all-cause mortality.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- harm key
- EG002
- source section id
- NCT03261947-ae
- event group key
- EG002
- event group label
- Metastatic CRC Cohort
- serious affected
- 8
- serious at risk
- 35
- other affected
- 27
- other at risk
- 35
- frequency threshold
- 5
- collection period
- All-Cause Mortality: Up to approximately 43 months; Serious and Other Adverse Events: From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
- event definition
- At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. A total of 67 deaths occurred in this study. Since all the information for death data could not be collected, not all deaths could be reported in all-cause mortality.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- harm key
- EG003
- source section id
- NCT03261947-ae
- event group key
- EG003
- event group label
- sqEC Cohort
- serious affected
- 5
- serious at risk
- 21
- other affected
- 14
- other at risk
- 21
- frequency threshold
- 5
- collection period
- All-Cause Mortality: Up to approximately 43 months; Serious and Other Adverse Events: From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
- event definition
- At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. A total of 67 deaths occurred in this study. Since all the information for death data could not be collected, not all deaths could be reported in all-cause mortality.
- 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-pancreatic-cancer-gemcitabine-e75727ad
- nct id
- NCT03261947
- harm key
- EG004
- source section id
- NCT03261947-ae
- event group key
- EG004
- event group label
- sqNSCLC Cohort
- serious affected
- 3
- serious at risk
- 18
- other affected
- 14
- other at risk
- 18
- frequency threshold
- 5
- collection period
- All-Cause Mortality: Up to approximately 43 months; Serious and Other Adverse Events: From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
- event definition
- At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. A total of 67 deaths occurred in this study. Since all the information for death data could not be collected, not all deaths could be reported in all-cause mortality.
- 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