Trial Outcomes & Findings for NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) (NCT NCT03107988)
NCT ID: NCT03107988
Last Updated: 2025-09-15
Results Overview
Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A1
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
All toxicities from enrollment until completion of course 2 (Day 56)
Results posted on
2025-09-15
Participant Flow
Participant milestones
| Measure |
Cohort A1 DL1
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL 3A
Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A Expansion
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B2 DL4B
Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL5B
Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL3A
Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL4A
Lorlatinib will be given orally once daily continuously for 28 days at 150mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
10
|
6
|
6
|
6
|
4
|
6
|
3
|
13
|
1
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
1
|
4
|
5
|
4
|
6
|
3
|
5
|
2
|
9
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
6
|
1
|
2
|
0
|
1
|
1
|
1
|
4
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A1 DL1
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL 3A
Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A Expansion
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B2 DL4B
Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL5B
Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL3A
Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL4A
Lorlatinib will be given orally once daily continuously for 28 days at 150mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease Progression or Relapse
|
1
|
2
|
2
|
5
|
1
|
1
|
0
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Overall Study
Ineligible
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
Baseline characteristics by cohort
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=10 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL 3A
n=6 Participants
Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A
n=6 Participants
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A Expansion
n=4 Participants
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
n=5 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B2 DL4B
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL5B
n=13 Participants
Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL3A
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL4A
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days at 150mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
48 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
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
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
35 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
29 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
56 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
45 Participants
n=36 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: All toxicities from enrollment until completion of course 2 (Day 56)Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A1
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=5 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
MTD/RP2D Determination A1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: All toxicities from enrollment until completion of course 2 (Day 56)Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A2
Outcome measures
| Measure |
Cohort A1 DL1
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=4 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
MTD/RP2D Determination A2
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: All toxicities from enrollment until completion of course 1 (Day 28)Proportion of patients with course 1 DLT in cohort B2
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=12 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
MTD/RP2D Determination B2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients with any grade 3 or greater non-hematological toxicities on any course in A1 and B1
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=10 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
n=5 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Describe Non-Hematological Toxicities (A1 and B1)
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients with any grade 3 or greater hematological toxicities on any course in A1 and B1
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=10 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
n=5 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Describe Hematological Toxicities (A1 and B1)
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients with any grade 3 or greater non-hematological toxicities in A2
Outcome measures
| Measure |
Cohort A1 DL1
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=4 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Describe Non-Hematological Toxicities (A2)
|
6 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients with any grade 3 or greater hematological toxicities in A2
Outcome measures
| Measure |
Cohort A1 DL1
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=4 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Describe Hematological Toxicities (A2)
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients with any grade 3 or greater non-hematological toxicities in B2
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=13 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Describe Non-Hematological Toxicities (B2)
|
3 Participants
|
12 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients with any grade 3 or greater hematological toxicities in B2
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=13 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Describe Hematological Toxicities (B2)
|
3 Participants
|
12 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose)Population: No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.
Steady State AUC for lorlatinib in patients in cohort A1 and B1
Outcome measures
| Measure |
Cohort A1 DL1
n=2 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics A1 and B1-Steady State AUC
|
1872 hours*ng/mL
Interval 1074.93 to 2669.08
|
2663.49 hours*ng/mL
Interval 2663.49 to 2663.49
|
2084.81 hours*ng/mL
Interval 2084.81 to 2084.81
|
7431.06 hours*ng/mL
Interval 3021.81 to 8906.31
|
5655.05 hours*ng/mL
Interval 4724.92 to 10910.87
|
NA hours*ng/mL
No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.
|
SECONDARY outcome
Timeframe: Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose)Steady State AUC for lorlatinib in patients in cohort A2
Outcome measures
| Measure |
Cohort A1 DL1
n=2 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics A2-Steady State AUC
|
9217.85 hours*ng/mL
Interval 7267.6 to 11168.1
|
4492.92 hours*ng/mL
Interval 3993.55 to 5139.0
|
5383.5 hours*ng/mL
Interval 4629.88 to 5747.95
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose)Population: No AUCtau is included for patients in Cohort B2 DL4B or Cohort B2 DL3A as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.
Steady State AUC for lorlatinib in patients in cohort B2
Outcome measures
| Measure |
Cohort A1 DL1
n=2 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=7 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics B2-Steady State AUC
|
NA hours*ng/mL
No AUCtau is included for patients in Cohort B2 DL4B as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.
|
6310.38 hours*ng/mL
Interval 4695.62 to 14106.75
|
NA hours*ng/mL
No AUCtau is included for patients in Cohort B2 DL3A as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable.
|
7594.16 hours*ng/mL
Interval 7594.16 to 7594.16
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in cohort A1 and B1
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=9 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
n=5 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Overall Response A1 and B1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in cohort A2
Outcome measures
| Measure |
Cohort A1 DL1
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=4 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Overall Response A2
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 monthsProportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in cohort B2
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=12 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Overall Response B2
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15Cmax for lorlatinib in patients in cohort A1 and B1
Outcome measures
| Measure |
Cohort A1 DL1
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=9 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics A1 and B1-Cmax
|
287 ng/mL
Interval 243.0 to 639.0
|
558 ng/mL
Interval 343.0 to 623.0
|
659 ng/mL
Interval 609.0 to 670.0
|
1100 ng/mL
Interval 590.0 to 1880.0
|
1280 ng/mL
Interval 708.0 to 2090.0
|
1800 ng/mL
Interval 1800.0 to 1800.0
|
SECONDARY outcome
Timeframe: Day 15Cmax for lorlatinib in patients in cohort A2
Outcome measures
| Measure |
Cohort A1 DL1
n=5 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=6 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=4 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics A2-Cmax
|
569 ng/mL
Interval 341.0 to 1830.0
|
710 ng/mL
Interval 502.0 to 912.0
|
878.5 ng/mL
Interval 602.0 to 1100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15Cmax for lorlatinib in patients in cohort B2
Outcome measures
| Measure |
Cohort A1 DL1
n=2 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=11 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=1 Participants
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics B2-Cmax
|
823.5 ng/mL
Interval 721.0 to 926.0
|
1440 ng/mL
Interval 83.0 to 3340.0
|
526 ng/mL
Interval 526.0 to 526.0
|
1490 ng/mL
Interval 1490.0 to 1490.0
|
—
|
—
|
Adverse Events
Cohort A1 DL1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort A1 DL2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort A1 DL3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort A1 DL4
Serious events: 3 serious events
Other events: 9 other events
Deaths: 9 deaths
Cohort A1 DL5
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Cohort A2 DL 3A
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Cohort A2 DL4A
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Cohort A2 DL4A Expansion
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B1 DL5
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
Cohort B2 DL4B
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort B2 DL5B
Serious events: 10 serious events
Other events: 12 other events
Deaths: 7 deaths
Cohort B2 DL3A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B2 DL4A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A1 DL1
n=3 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=10 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=6 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL 3A
n=6 participants at risk
Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A
n=6 participants at risk
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A Expansion
n=4 participants at risk
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
n=5 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B2 DL4B
n=3 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL5B
n=13 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL3A
n=1 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL4A
n=1 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days at 150mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
46.2%
6/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Fever
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Multi-organ failure
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
TRANSFUSION-ASSOCIATED CIRCULATORY OVERLOAD
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Hepatobiliary disorders
BILIARY OBSTRUCTION
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
COVID 19
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Catheter related infection
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Flu like symptoms
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CARCINOMA
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Mania
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
Other adverse events
| Measure |
Cohort A1 DL1
n=3 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL2
n=3 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL3
n=3 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL4
n=10 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A1 DL5
n=6 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL 3A
n=6 participants at risk
Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A
n=6 participants at risk
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort A2 DL4A Expansion
n=4 participants at risk
Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B1 DL5
n=5 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
|
Cohort B2 DL4B
n=3 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL5B
n=13 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL3A
n=1 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
Cohort B2 DL4A
n=1 participants at risk
Lorlatinib will be given orally once daily continuously for 28 days at 150mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment.
Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy.
Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Mania
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Personality change
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
REPORT OF FEELING "EMOTIONALLY NUMB"
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
70.0%
7/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
60.0%
3/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
92.3%
12/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
38.5%
5/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
ABNORMAL EYE MOVEMENTS
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Eye disorders
SUBCONJUNCTIVAL HEMORRHAGE
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
38.5%
5/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
83.3%
5/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
53.8%
7/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
4/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
75.0%
3/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
38.5%
5/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
5/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
53.8%
7/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Chills
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Edema face
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
4/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
61.5%
8/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Fever
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
4/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
46.2%
6/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Flu like symptoms
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Irritability
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Localized edema
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Malaise
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
General disorders
Pain
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
ASTROVIRUS
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Bladder infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
COVID 19
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.8%
4/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Catheter related infection
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Cervicitis infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Flu like symptoms
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Lip infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Otitis media
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Infections and infestations
Vulval infection
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
60.0%
6/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
83.3%
5/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
80.0%
4/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
46.2%
6/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
5/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
61.5%
8/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
70.0%
7/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
5/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
46.2%
6/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Cholesterol high
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
5/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
83.3%
5/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
75.0%
3/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
5/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
92.3%
12/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
38.5%
5/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
ELEVATED CRP
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
ELEVATED SED RATE
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
GGT increased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
HYPERPHOSPHATEMIA
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Hemoglobin increased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
INCREASED UREA
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
LDH INCREASE
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
5/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
83.3%
5/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
84.6%
11/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
NAIL CHANGES
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
NEUTROPHIL COUNT INCREASED
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
92.3%
12/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Pancreatic enzymes decreased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
83.3%
5/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
92.3%
12/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Weight gain
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
60.0%
6/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
83.3%
5/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
75.0%
3/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
80.0%
4/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
69.2%
9/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
Weight loss
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
92.3%
12/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
46.2%
6/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
60.0%
3/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
38.5%
5/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
38.5%
5/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
80.0%
8/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
6/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
75.0%
3/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
80.0%
4/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
92.3%
12/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
5/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.8%
4/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
5/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.8%
4/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.8%
4/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.8%
4/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
INCREASED APPETITE
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Metabolism and nutrition disorders
LDL DIRECT INCREASED
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
CRAMPS
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
PATELLAR SUBFIXATION
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CARCINOMA
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Cognitive disturbance
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Concentration impairment
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
4/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
4/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.8%
4/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Recurrent laryngeal nerve palsy
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
STAMMERING
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
STUTTERING
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
83.3%
5/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.8%
4/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Euphoria
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
30.0%
3/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
38.5%
5/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
LEFT HYDROURETER
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
NOCTURNAL ENURESIS
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Reproductive system and breast disorders
Premature menopause
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
4/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
4/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
60.0%
3/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
46.2%
6/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
3/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
2/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
3/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
66.7%
2/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
38.5%
5/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Body odor
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
20.0%
1/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
ECCHYMOTIC NODULE
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
HERPES SIMPLEX REACTIVATION
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
2/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
15.4%
2/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
50.0%
2/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
10.0%
1/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
16.7%
1/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
25.0%
1/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
40.0%
2/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
23.1%
3/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/10 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/6 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/4 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/5 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
33.3%
1/3 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
7.7%
1/13 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
100.0%
1/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
0.00%
0/1 • Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
|
Additional Information
NANT Medical Director
New Approaches to Neuroblastoma Therapy
Phone: 3233615687
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place