Trial Outcomes & Findings for A Study of LY3415244 in Participants With Advanced Solid Tumors (NCT NCT03752177)
NCT ID: NCT03752177
Last Updated: 2021-10-22
Results Overview
A DLT was defined as an adverse event (AE) occurring during Cycle 1(28 days) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \[NCI-CTCAE v 4.0\] \[NCI 2009\]):Grade 3 thrombocytopenia requiring platelet transfusion or grade 4 thrombocytopenia. Grade greater than or equal to (≥) 3 febrile neutropenia, anemia requiring a blood transfusion and any other Grade 4 hematologic toxicity that last \>7 days. Grade ≥ 3 colitis or noninfectious pneumonitis, Grade ≥ 3 fatigue lasting \>7 days, Grade ≥ 3 hypertension despite of maximal medical therapy. Grade 4 immune-related adverse event (irAE), liver transaminase elevation \>8x upper limit of normal (ULN) or total bilirubin \>3x ULN.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Baseline through Cycle 1 (28 Day Cycle)
Results posted on
2021-10-22
Participant Flow
Phase 1a of study consisted of dose-escalation assessment and Phase 1b of study included dose expansion. Four out of planned eight cohorts (one optional) in Phase 1a were completed. Phase 1b dose expansion was planned but not initiated as dose escalation ended at cohort A4.A participant completed study if they completed at least 1 cycle (28 days).
Participant milestones
| Measure |
Cohort A1
Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
|
Cohort A2
Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A3
Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A4
Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3415244 in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort A1
n=3 Participants
Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
|
Cohort A2
n=3 Participants
Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A3
n=3 Participants
Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A4
n=3 Participants
Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.33 years
STANDARD_DEVIATION 2.31 • n=5 Participants
|
57.00 years
STANDARD_DEVIATION 11.36 • n=7 Participants
|
48.33 years
STANDARD_DEVIATION 20.60 • n=5 Participants
|
55.67 years
STANDARD_DEVIATION 3.79 • n=4 Participants
|
53.58 years
STANDARD_DEVIATION 10.77 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Cycle 1 (28 Day Cycle)Population: All participants who received at least 1 dose of study drug and had evaluable DLT data.
A DLT was defined as an adverse event (AE) occurring during Cycle 1(28 days) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \[NCI-CTCAE v 4.0\] \[NCI 2009\]):Grade 3 thrombocytopenia requiring platelet transfusion or grade 4 thrombocytopenia. Grade greater than or equal to (≥) 3 febrile neutropenia, anemia requiring a blood transfusion and any other Grade 4 hematologic toxicity that last \>7 days. Grade ≥ 3 colitis or noninfectious pneumonitis, Grade ≥ 3 fatigue lasting \>7 days, Grade ≥ 3 hypertension despite of maximal medical therapy. Grade 4 immune-related adverse event (irAE), liver transaminase elevation \>8x upper limit of normal (ULN) or total bilirubin \>3x ULN.
Outcome measures
| Measure |
Cohort A1
n=3 Participants
Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
|
Cohort A2
n=3 Participants
Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A3
n=3 Participants
Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A4
n=2 Participants
Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
|---|---|---|---|---|
|
Phase1a: Number of Participants With LY3415244 Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (C1D1) and C1D15: pre-dose, 2 hours(h), 4h, 24h, 72h, 120h and 168h post-dose; C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C5D15, C6D1 and C6D15: pre-dosePopulation: All participants who received at least 1 dose of study drug with evaluable PK data.
Cmin of LY3415244 was evaluated.
Outcome measures
| Measure |
Cohort A1
n=3 Participants
Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
|
Cohort A2
n=3 Participants
Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A3
n=3 Participants
Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A4
n=3 Participants
Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
|---|---|---|---|---|
|
Phase1a: Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3415244
Cycle 1 Day 15
|
—
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual value of Cmin = 151 ng/mL.
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmin = 146 ng/mL, 8240 ng/mL.
|
—
|
|
Phase1a: Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3415244
Cycle 1 Day 1
|
—
|
—
|
NA nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual value of Cmin = 5790 ng/mL.
|
4270 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Baseline through Measured Progressive Disease (Up To 24 Months)Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion.
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months)Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion.
Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Date of CR or PR (Up To 24 Months)Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion.
Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion. Time to treatment response was defined as date of first dose of study drug to the date of confirmed complete response (CR) or partial response (PR) using Response evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Measured Progressive Disease (Up To 24 Months)Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion.
DCR is the percentage of participants with a best overall response of CR, PR or stable disease (SD) as defined by RECIST v1.1. CR is defined as disappearance of all target and non-target lesions and no appearance of new lesions.PR is defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions (taking as reference the baseline sum LD),no progression of non-target lesions, and no appearance of new lesions.SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Objective Progression or Death Due to Any Cause (Up To 24 Months)Population: Zero participants were analyzed for this outcome. Data were not captured as study was terminated early and no participant were enrolled into Phase 1b expansion.
Progression-free survival time was measured from treatment start until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Patients who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of treatment start if no post-baseline radiographic assessment is available.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort A2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A1
n=3 participants at risk
Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
|
Cohort A2
n=3 participants at risk
Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A3
n=3 participants at risk
Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A4
n=3 participants at risk
Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
Other adverse events
| Measure |
Cohort A1
n=3 participants at risk
Participants received 3 milligrams (mg) LY3415244 as an intravenous (IV) infusion on day (D)1 and D15 of each 28-day cycle every 2 weeks (Q2W).
|
Cohort A2
n=3 participants at risk
Participants received 10 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A3
n=3 participants at risk
Participants received 30 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
Cohort A4
n=3 participants at risk
Participants received 70 mg LY3415244 as an IV infusion on D1 and D15 of each 28-day cycle Q2W.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
Weight increased
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Investigations
White blood cell count increased
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 4 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
66.7%
2/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
66.7%
2/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Acne
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Eye disorders
Eye movement disorder
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Eye disorders
Eyelid ptosis
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
66.7%
2/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
100.0%
3/3 • Number of events 3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
66.7%
2/3 • Number of events 2 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Infections and infestations
Paronychia
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
33.3%
1/3 • Number of events 1 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
0.00%
0/3 • Up To 24 Months
All enrolled participants. Gastrointestinal stoma complication was not treatment related adverse event and the Infusion related reaction is treatment related adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI must delay publications until a multi-center publication is disclosed, (or for a time period if no multi-center publication is disclosed).
- Publication restrictions are in place
Restriction type: OTHER