NCT03621982 · STUDY IN CONTEXT
Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
Draft scope assessment: unclear. Attached because the study's own record describes locally advanced 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
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms, 2 is moderate, 3 is severe, 4 is Life-threatening consequences and 5 is death related to an AE.
A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 is mild or asymptomatic, 2 is moderate, 3 is severe, 4 is Life-threatening and 5 is death related to an AE.
Dose interruption for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
Dose reductions for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
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-locally-advanced-06747430
- nct id
- NCT03621982
- trial label
- Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
- applicability
- unclear
- applicability note
- Attached because the study's own record describes locally advanced 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
- 14
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- source section id
- NCT03621982-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
- endpoint definition
- An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
- time origin
- Up to 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0001
- source section id
- NCT03621982-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade
- endpoint definition
- AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms, 2 is moderate, 3 is severe, 4 is Life-threatening consequences and 5 is death related to an AE.
- time origin
- Up to 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set: The Safety analysis set consists of all participants who received study drug and experienced TEAEs only.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0002
- source section id
- NCT03621982-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs)
- endpoint definition
- A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
- time origin
- Up to 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0003
- source section id
- NCT03621982-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants Who Experienced a SAE by CTCAE Grade
- endpoint definition
- AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 is mild or asymptomatic, 2 is moderate, 3 is severe, 4 is Life-threatening and 5 is death related to an AE.
- time origin
- Up to 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set: The Safety analysis set consists of all participants who received study drug. Analysis only included participants with SAEs.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0004
- source section id
- NCT03621982-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants Who Experienced a Dose Interruption
- endpoint definition
- Dose interruption for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
- time origin
- Up to 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0005
- source section id
- NCT03621982-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants Who Experienced a Dose Reduction
- endpoint definition
- Dose reductions for participants treated with ADCT-301 as monotherapy and for participants treated with ADCT-301 in combination with pembrolizumab.
- time origin
- Up to 3 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG000
- arm label
- ADCT-301 Monotherapy 20 µg/kg
- regimen
- Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG001
- arm label
- ADCT-301 Monotherapy 30 µg/kg
- regimen
- Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG002
- arm label
- ADCT-301 Monotherapy 45 µg/kg
- regimen
- Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG003
- arm label
- ADCT-301 Monotherapy 60 µg/kg
- regimen
- Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG004
- arm label
- ADCT-301 Monotherapy 80 µg/kg
- regimen
- Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG005
- arm label
- ADCT-301 Monotherapy 100 µg/kg
- regimen
- Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG006
- arm label
- ADCT-301 Monotherapy 125 µg/kg
- regimen
- Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG007
- arm label
- ADCT-301 Monotherapy 150 µg/kg
- regimen
- Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG008
- arm label
- ADCT-301 Combination Therapy 20 µg/kg + Pemb
- regimen
- Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG009
- arm label
- ADCT-301 Combination Therapy 30 µg/kg + Pemb
- regimen
- Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG009
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG010
- arm label
- ADCT-301 Combination Therapy 45 µg/kg + Pemb
- regimen
- Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG010
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- outcome key
- om-0000
- arm key
- OG011
- arm label
- ADCT-301 Combination Therapy 60 µg/kg + Pemb
- regimen
- Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03621982-om-0000#groups/OG011
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG000
- source section id
- NCT03621982-ae
- event group key
- EG000
- event group label
- ADCT-301 Monotherapy 20 µg/kg
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG001
- source section id
- NCT03621982-ae
- event group key
- EG001
- event group label
- ADCT-301 Monotherapy 30 µg/kg
- serious affected
- 1
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG002
- source section id
- NCT03621982-ae
- event group key
- EG002
- event group label
- ADCT-301 Monotherapy 45 µg/kg
- serious affected
- 2
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG003
- source section id
- NCT03621982-ae
- event group key
- EG003
- event group label
- ADCT-301 Monotherapy 60 µg/kg
- serious affected
- 3
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG004
- source section id
- NCT03621982-ae
- event group key
- EG004
- event group label
- ADCT-301 Monotherapy 80 µg/kg
- serious affected
- 3
- serious at risk
- 8
- other affected
- 8
- other at risk
- 8
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG005
- source section id
- NCT03621982-ae
- event group key
- EG005
- event group label
- ADCT-301 Monotherapy 100 µg/kg
- serious affected
- 1
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG006
- source section id
- NCT03621982-ae
- event group key
- EG006
- event group label
- ADCT-301 Monotherapy 125 µg/kg
- serious affected
- 3
- serious at risk
- 8
- other affected
- 8
- other at risk
- 8
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG007
- source section id
- NCT03621982-ae
- event group key
- EG007
- event group label
- ADCT-301 Monotherapy 150 µg/kg
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG008
- source section id
- NCT03621982-ae
- event group key
- EG008
- event group label
- ADCT-301 Combination Therapy 20 µg/kg + Pemb
- serious affected
- 1
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG009
- source section id
- NCT03621982-ae
- event group key
- EG009
- event group label
- ADCT-301 Combination Therapy 30 µg/kg + Pemb
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG010
- source section id
- NCT03621982-ae
- event group key
- EG010
- event group label
- ADCT Combination Therapy 45 µg/kg + Pemb
- serious affected
- 5
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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-locally-advanced-06747430
- nct id
- NCT03621982
- harm key
- EG011
- source section id
- NCT03621982-ae
- event group key
- EG011
- event group label
- ADCT Combination Therapy 60 µg/kg + Pemb
- serious affected
- 8
- serious at risk
- 9
- other affected
- 9
- other at risk
- 9
- frequency threshold
- 5
- collection period
- All SAEs and AEs were collected from the time the participant signs the ICF until 30 days after the last dose of study drug up to a maximum of 3 years.
- event definition
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment.
- 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
Triangle