Trial Outcomes & Findings for Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma (NCT NCT02855359)
NCT ID: NCT02855359
Last Updated: 2019-03-11
Results Overview
Study did not progress to Part B.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
N/A - Endpoint not assessed
Results posted on
2019-03-11
Participant Flow
Participant milestones
| Measure |
Denintuzumab Mafodotin + RCHP
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP or RCHP
Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
RCHOP
Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
0
|
0
|
Reasons for withdrawal
| Measure |
Denintuzumab Mafodotin + RCHP
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP or RCHP
Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
RCHOP
Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
|---|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
0
|
0
|
|
Overall Study
Study Termination by Sponsor
|
9
|
11
|
0
|
0
|
Baseline Characteristics
Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Denintuzumab Mafodotin + RCHP
n=11 Participants
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP
n=13 Participants
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
72 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0: Normal activity
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1: Symptoms, but ambulatory
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2: In bed less than 50% of the time
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: N/A - Endpoint not assessedPopulation: Endpoint not assessed; study did not progress to Part B.
Study did not progress to Part B.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 54.7 weeksPart A data only; study did not progress to Part B.
Outcome measures
| Measure |
Denintuzumab Mafodotin + RCHP
n=11 Participants
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP
n=13 Participants
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP or RCHP
Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
RCHOP
Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
|---|---|---|---|---|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any DM treatment-related AE
|
9 Participants
|
13 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any RCHOP/RCHP treatment-related AE
|
10 Participants
|
13 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any Treatment-Related SAE
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any Treatment-emergent adverse event (TEAE)
|
11 Participants
|
13 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any Grade 3-5 TEAE
|
11 Participants
|
12 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any Treatment-related Adverse Event (AE)
|
10 Participants
|
13 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any AE with Outcome of Death
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any Serious Adverse Event (SAE)
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Adverse Events
Any DM Treatment-Related SAE
|
2 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 183 daysPart A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.
Outcome measures
| Measure |
Denintuzumab Mafodotin + RCHP
n=11 Participants
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP
n=13 Participants
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP or RCHP
Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
RCHOP
Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
|---|---|---|---|---|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Blood bilirubin increased
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypercalcemia
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypocalcemia
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hyperglycemia
|
8 Participants
|
11 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypoglycemia
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypermagnesemia
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypomagnesemia
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypophosphatemia
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypokalemia
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypernatremia
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hyponatremia
|
4 Participants
|
12 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hyperuricemia
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Anemia
|
10 Participants
|
12 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Leukopenia
|
10 Participants
|
13 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Lymphopenia
|
9 Participants
|
13 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Neutropenia
|
9 Participants
|
11 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Thrombocytopenia
|
10 Participants
|
13 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Hypoalbuminemia
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Alanine aminotransferase increased
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Alkaline phosphatase increased
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities
Aspartate aminotransferase increased
|
5 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: N/A - Endpoint not assessedPopulation: Endpoint not assessed; study did not progress to Part B.
Study did not progress to Part B
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - Endpoint not assessedPopulation: Endpoint not assessed; study did not progress to Part B.
Study did not progress to Part B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - Endpoint not assessedPopulation: Endpoint not assessed; study did not progress to Part B.
Study did not progress to Part B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - Endpoint not assessedPopulation: Endpoint not assessed; study did not progress to Part B.
Study did not progress to Part B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: N/A - Endpoint not assessedPopulation: Endpoint not assessed; study did not progress to Part B.
Study did not progress to Part B.
Outcome measures
Outcome data not reported
Adverse Events
Denintuzumab Mafodotin + RCHP
Serious events: 5 serious events
Other events: 11 other events
Deaths: 2 deaths
Denintuzumab Mafodotin + RCHOP
Serious events: 4 serious events
Other events: 13 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Denintuzumab Mafodotin + RCHP
n=11 participants at risk
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP
n=13 participants at risk
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
18.2%
2/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
General disorders
Asthenia
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
General disorders
Fatigue
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
Other adverse events
| Measure |
Denintuzumab Mafodotin + RCHP
n=11 participants at risk
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
Denintuzumab Mafodotin + RCHOP
n=13 participants at risk
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
denintuzumab mafodotin: SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
|
|---|---|---|
|
Eye disorders
Vision blurred
|
63.6%
7/11 • 54.7 weeks
|
76.9%
10/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
54.5%
6/11 • 54.7 weeks
|
61.5%
8/13 • 54.7 weeks
|
|
General disorders
Fatigue
|
63.6%
7/11 • 54.7 weeks
|
46.2%
6/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
54.5%
6/11 • 54.7 weeks
|
46.2%
6/13 • 54.7 weeks
|
|
Eye disorders
Keratopathy
|
45.5%
5/11 • 54.7 weeks
|
46.2%
6/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • 54.7 weeks
|
46.2%
6/13 • 54.7 weeks
|
|
Eye disorders
Dry eye
|
27.3%
3/11 • 54.7 weeks
|
53.8%
7/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • 54.7 weeks
|
53.8%
7/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.2%
2/11 • 54.7 weeks
|
46.2%
6/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.2%
2/11 • 54.7 weeks
|
38.5%
5/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
27.3%
3/11 • 54.7 weeks
|
30.8%
4/13 • 54.7 weeks
|
|
General disorders
Pyrexia
|
27.3%
3/11 • 54.7 weeks
|
30.8%
4/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
27.3%
3/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Vascular disorders
Hypotension
|
18.2%
2/11 • 54.7 weeks
|
30.8%
4/13 • 54.7 weeks
|
|
Eye disorders
Keratitis
|
9.1%
1/11 • 54.7 weeks
|
38.5%
5/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • 54.7 weeks
|
30.8%
4/13 • 54.7 weeks
|
|
Nervous system disorders
Headache
|
36.4%
4/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
9.1%
1/11 • 54.7 weeks
|
30.8%
4/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
2/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Eye disorders
Visual acuity reduced
|
9.1%
1/11 • 54.7 weeks
|
30.8%
4/13 • 54.7 weeks
|
|
General disorders
Asthenia
|
9.1%
1/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
18.2%
2/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
1/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Eye disorders
Lacrimation increased
|
9.1%
1/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
General disorders
Mucosal inflammation
|
18.2%
2/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
9.1%
1/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
General disorders
Chills
|
18.2%
2/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Eye disorders
Eye pain
|
18.2%
2/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Eye disorders
Eye pruritus
|
9.1%
1/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.1%
1/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
18.2%
2/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/11 • 54.7 weeks
|
23.1%
3/13 • 54.7 weeks
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Eye disorders
Photophobia
|
9.1%
1/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Investigations
White blood cell count decreased
|
9.1%
1/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.2%
2/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
18.2%
2/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Eye disorders
Eye irritation
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Infections and infestations
Fungal infection
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
18.2%
2/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Eye disorders
Ocular toxicity
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Oral candidiasis
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Oral disorder
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/11 • 54.7 weeks
|
15.4%
2/13 • 54.7 weeks
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Investigations
Troponin increased
|
9.1%
1/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Eye disorders
Asthenopia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Investigations
Blood creatinine increased
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Bronchitis
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Infections and infestations
Candida infection
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Eye disorders
Cataract
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Eye disorders
Corneal oedema
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Eye disorders
Corneal opacity
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Eye disorders
Diplopia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Eye infection fungal
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Eye disorders
Eye oedema
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Fungal skin infection
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
General disorders
Generalised oedema
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Eye disorders
Glaucoma
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Glossodynia
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Nervous system disorders
Lethargy
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Eye disorders
Macular degeneration
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
General disorders
Non-cardiac chest pain
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
General disorders
Pain
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Vascular disorders
Pallor
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Pharyngitis
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Infections and infestations
Skin infection
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Eye disorders
Vitreous floaters
|
9.1%
1/11 • 54.7 weeks
|
0.00%
0/13 • 54.7 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/11 • 54.7 weeks
|
7.7%
1/13 • 54.7 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place