Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma (NCT NCT06069778)

Results Overview

TEAEs graded per Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0), including Grade ≥3, serious, fatal TEAE by relationship.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

from the start of study drug treatment until the end of study (i.e., 164 days)

Results posted on

2025-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1 - BNT321 0.5 mg/kg + mFOLFIRINOX BNT321 in combination with mFOLFIRINOX chemotherapy. mFOLFIRINOX: Administered as intravenous infusion on the first day of each 14-day cycle (i.e., C1D1, C2D1, C3D1, and so on for a total of 12 cycles) using the following agent, oxaliplatin (Day 1), leucovorin (Day 1), irinotecan (Day 1, starting 30 minutes after leucovorin), and 5-fluorouracil (Day 1). BNT321: Administered as intravenous infusion and incorporated into the mFOLFIRINOX regimen starting from the second cycle and after the completion of the 5-fluorouracil infusion (e.g., initially on C2D3).
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 - BNT321 0.5 mg/kg + mFOLFIRINOX BNT321 in combination with mFOLFIRINOX chemotherapy. mFOLFIRINOX: Administered as intravenous infusion on the first day of each 14-day cycle (i.e., C1D1, C2D1, C3D1, and so on for a total of 12 cycles) using the following agent, oxaliplatin (Day 1), leucovorin (Day 1), irinotecan (Day 1, starting 30 minutes after leucovorin), and 5-fluorouracil (Day 1). BNT321: Administered as intravenous infusion and incorporated into the mFOLFIRINOX regimen starting from the second cycle and after the completion of the 5-fluorouracil infusion (e.g., initially on C2D3).
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 - BNT321 0.5 mg/kg + mFOLFIRINOX n=1 Participants BNT321 in combination with mFOLFIRINOX chemotherapy. mFOLFIRINOX: Administered as intravenous infusion on the first day of each 14-day cycle (i.e., C1D1, C2D1, C3D1, and so on for a total of 12 cycles) using the following agent, oxaliplatin (Day 1), leucovorin (Day 1), irinotecan (Day 1, starting 30 minutes after leucovorin), and 5-fluorouracil (Day 1). BNT321: Administered as intravenous infusion and incorporated into the mFOLFIRINOX regimen starting from the second cycle and after the completion of the 5-fluorouracil infusion (e.g., initially on C2D3).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex/Gender, Customized Not disclosed to avoid re-identification	1 Participants n=5 Participants
Race/Ethnicity, Customized Not disclosed to avoid re-identification	1 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: from the start of study drug treatment until the end of study (i.e., 164 days)

Population: Analysis was performed on the safety set that included all participants who received at least one dose of the investigational medicinal product (IMP).

TEAEs graded per Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0), including Grade ≥3, serious, fatal TEAE by relationship.

Outcome measures

Outcome measures
Measure	Phase 1 - BNT321 0.5 mg/kg + mFOLFIRINOX n=1 Participants BNT321 in combination with mFOLFIRINOX chemotherapy. mFOLFIRINOX: Administered as intravenous infusion on the first day of each 14-day cycle (i.e., C1D1, C2D1, C3D1, and so on for a total of 12 cycles) using the following agent, oxaliplatin (Day 1), leucovorin (Day 1), irinotecan (Day 1, starting 30 minutes after leucovorin), and 5-fluorouracil (Day 1). BNT321: Administered as intravenous infusion and incorporated into the mFOLFIRINOX regimen starting from the second cycle and after the completion of the 5-fluorouracil infusion (e.g., initially on C2D3).	Phase 2 - mFOLFIRINOX mFOLFIRINOX chemotherapy (24 weeks) as monotherapy mFOLFIRINOX: Intravenous infusion
Phase 1 - The Number and Percentage of Participants With at Least One Dose of Investigational Medicinal Product (IMP) Reporting Treatment Emergent Adverse Events (TEAEs)	1 Participants	—

PRIMARY outcome

Timeframe: up to 28 days after first dose of BNT321

Population: The participant was not evaluable for DLT due to not satisfying the minimum exposure criterion as defined in the protocol.

For all Phase I cohorts the DLT assessment period was planned to encompass the treatment cycles of the first two consecutive BNT321 doses, i.e., 28 days within treatment Cycles 2 and 3. To be considered a DLT, an AE must have met the following three criteria: * Occurred during the DLT assessment period of BNT321. * Was considered BNT321-related (i.e., definitely related or possibly related). * Occurred in the presence of adequate supportive care (e.g., Grade 3 vomiting despite use of an appropriate anti-emetic regimen). In addition, to be considered a DLT, an AE must have met at least one of the additional criteria using CTCAE v5.0 as specified in the protocol.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 60 months

Population: Due to early termination of the study, no participant was included in the Phase 2 part of the study.

DFS was defined as the time from randomization to occurrence of any of the following events, whichever occurs first: * Locoregional recurrence or distant metastases as determined by an independent central radiology assessment. * Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment. * Death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 60 months

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. The participant was followed up for efficacy for a short period of time while on study (\~6 months), therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of OS. No participant was included in the Phase 2 part of the study.

OS was defined as the time from first dose of study treatment to death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 60 months

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. The participant was followed up for efficacy for a short period of time while on study (\~6 months) and disease was not relapsed, therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of RFS. No participant was included in the Phase 2 part of the study.

RFS is defined as the time from randomization to occurrence of any of the following events, whichever occurs first: * Locoregional recurrence or distant metastasis as determined by the investigator. * Death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. Therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of the mean AUC. No participant was included in the Phase 2 part of the study.

Mean AUC from participants who are dosed with at least one dose of IMP and who have evaluable PK data in Cycles 2 and 3 followed by sparse sampling through end of study (EOT).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. Therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of Cmax. No participant was included in the Phase 2 part of the study.

Mean Cmax from participants who are dosed with at least one dose of IMP and who have evaluable PK data in Cycles 2 and 3 followed by sparse sampling through EOT.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. Therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of Tmax. No participant was included in the Phase 2 part of the study.

Median tmax from participants who are dosed with at least one dose of IMP and who have evaluable PK data in Cycles 2 and 3 followed by sparse sampling through EOT.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. The participant was followed up for a short period of time while on study (\~6 months), therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of detectable ADA. No participant was included in the Phase 2 part of the study.

Percentage of participants who are dosed with at least one dose of IMP and with detectable ADA formation in Cycles 1 and 3, followed by sparse sampling through EOT

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. The participant was followed up for a short period of time while on study (\~6 months), therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of detectable and durable ADCC and/or CDC activity No participant was included in the Phase 2 part of the study.

Percentage of participants who are dosed with at least one dose of IMP with detectable and durable (measurable throughout time on study) ADCC and/or CDC activity in Cycles 2 and 4, followed by sparse sampling through EOT

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 60 months

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. The participant was followed up for efficacy for a short period of time while on study (\~6 months), therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of HRQoL. No participant was included in the Phase 2 part of the study.

Change from baseline at end of Cycle 12 for participant-reported HRQoL using EORTC QLQ-C30

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 60 months

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. The participant was followed up for efficacy for a short period of time while on study (\~6 months), therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of HRQoL. No participant was included in the Phase 2 part of the study.

Change from baseline at end of Cycle 12 for participant-reported HRQoL using EORTC QLQ-Pan26 questionnaires

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 60 months

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. The participant was followed up for efficacy for a short period of time while on study (\~6 months), therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of HRQoL. No participant was included in the Phase 2 part of the study.

Change from baseline at end of Cycle 12 in combined item scores from EORTC QLQ-C30

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 60 months

Population: Data were not available for this endpoint, due to early termination of the study after enrollment of one participant in the Phase 1 part. The participant was followed up for efficacy for a short period of time while on study (\~6 months), therefore there was insufficient data for the Phase 1 part to conduct a meaningful assessment of HRQoL. No participant was included in the Phase 2 part of the study.

Change from baseline at end of Cycle 12 in combined item scores from EORTC QLQ-Pan26.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 months

Population: Due to early termination of the study, no participant was included in the Phase 2 part of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 months

Population: Due to early termination of the study, no participant was included in the Phase 2 part of the study.

Occurrence within a participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 48 weeks

Population: Due to early termination of the study, no participant was included in the Phase 2 part of the study.

Occurrence within a participant.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1 - BNT321 0.5 mg/kg + mFOLFIRINOX

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phase 1 - BNT321 0.5 mg/kg + mFOLFIRINOX n=1 participants at risk BNT321 in combination with mFOLFIRINOX chemotherapy. mFOLFIRINOX: Administered as intravenous infusion on the first day of each 14-day cycle (i.e., C1D1, C2D1, C3D1, and so on for a total of 12 cycles) using the following agent, oxaliplatin (Day 1), leucovorin (Day 1), irinotecan (Day 1, starting 30 minutes after leucovorin), and 5-fluorouracil (Day 1). BNT321: Administered as intravenous infusion and incorporated into the mFOLFIRINOX regimen starting from the second cycle and after the completion of the 5-fluorouracil infusion (e.g., initially on C2D3).
Investigations Alanine aminotransferase increased	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Investigations Blood alkaline phosphatase increased	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Skin and subcutaneous tissue disorders Alopecia	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Investigations Aspartate aminotransferase increased	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Infections and infestations Conjunctivitis	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Investigations Gamma-glutamyltransferase increased	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Metabolism and nutrition disorders Hyperglycaemia	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Metabolism and nutrition disorders Hyperphosphataemia	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Metabolism and nutrition disorders Hyperuricaemia	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Metabolism and nutrition disorders Hypocalcaemia	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Metabolism and nutrition disorders Hypokalaemia	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Metabolism and nutrition disorders Hypophosphataemia	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Investigations Lymphocyte count decreased	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Investigations Lymphocyte count increased	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Gastrointestinal disorders Nausea	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Investigations Neutrophil count decreased	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Nervous system disorders Neuropathy peripheral	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.
Infections and infestations Pharyngitis	100.0% 1/1 • Deaths and serious adverse events (SAEs): All events from the signing of the study-specific informed consent from until the end of study (i.e., 175 days). Other adverse events (AEs): All TEAEs, i.e., AEs reported from the start of study drug treatment until the end of study (i.e., 164 days). Other AEs: All TEAEs, i.e., AEs with an onset date on or after the first dose of the IMP (if the AE was absent before the first dose) or worsened after the first dose of IMP (if the AE was present before the first dose). AEs with an onset date \>60 days after the last dose of IMP are included only if assessed as related to the IMP by the investigator.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigators respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
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