Trial Outcomes & Findings for AVID100 in Advanced Epithelial Carcinomas (NCT NCT03094169)
NCT ID: NCT03094169
Last Updated: 2025-06-11
Results Overview
Any of the following toxicities, if judged to be associated with study, were considered a DLT: 1. Evidence of pulmonary fibrosis 2. G3 non-hematologic toxicity regardless of duration with the exceptions of: * G3 nausea, vomiting, diarrhea, or fatigue lasting \< 2 days * G3 asymptomatic electrolyte abnormalities lasting \< 3 days not considered clinically relevant 3. AST and/or ALT elevation \> 3 x ULN with total bilirubin \> 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors 4. Any G4 non-hematologic toxicity with the exception of: • G4 asymptomatic electrolyte abnormalities lasting \< 7 days not considered clinically significant 5. Neutropenia that is: * \> G3 and associated with fever * G4 and sustained (ANC \< 500 per mm3, duration \> 5 days) 6. Thrombocytopenia that is: * G3 with clinically significant hemorrhage or requirement for transfusion * G4 (platelets \< 25,000 per mm3) 7. Inability to complete Cycle 1 at the assigned dose
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)
Results posted on
2025-06-11
Participant Flow
Participant milestones
| Measure |
AVID100 20 mg/m^2
Phase 1 Cohort 1: Participants were administered 20 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 40 mg/m^2
Phase 1 Cohort 2: Participants were administered 40 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 80 mg/m^2
Phase 1 Cohort 3: Participants were administered 80 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 120 mg/m^2
Phase 1 Cohort 4: Participants were administered 120 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 180 mg/m^2
Phase 1 Cohort 5: Participants were administered 180 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 220 mg/m^2
Phase 1 Cohort 6: Participants were administered 220 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 270 mg/m^2
Phase 1 Cohort 7: Participants were administered 270 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
Phase 2a Expansion: AVID100 220 mg/m^2
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
3
|
3
|
6
|
7
|
25
|
|
Overall Study
COMPLETED
|
1
|
1
|
3
|
3
|
3
|
6
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
25
|
Reasons for withdrawal
| Measure |
AVID100 20 mg/m^2
Phase 1 Cohort 1: Participants were administered 20 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 40 mg/m^2
Phase 1 Cohort 2: Participants were administered 40 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 80 mg/m^2
Phase 1 Cohort 3: Participants were administered 80 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 120 mg/m^2
Phase 1 Cohort 4: Participants were administered 120 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 180 mg/m^2
Phase 1 Cohort 5: Participants were administered 180 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 220 mg/m^2
Phase 1 Cohort 6: Participants were administered 220 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 270 mg/m^2
Phase 1 Cohort 7: Participants were administered 270 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
Phase 2a Expansion: AVID100 220 mg/m^2
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
21
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Trial Termination
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
AVID100 in Advanced Epithelial Carcinomas
Baseline characteristics by cohort
| Measure |
AVID100 20 mg/m^2
n=1 Participants
Phase 1 Cohort 1: Participants were administered 20 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 40 mg/m^2
n=1 Participants
Phase 1 Cohort 2: Participants were administered 40 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 80 mg/m^2 Cohort 3
n=3 Participants
Phase 1 Cohort 3: Participants were administered 80 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 120 mg/m^2
n=3 Participants
Phase 1 Cohort 4: Participants were administered 120 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 180 mg/m^2
n=3 Participants
Phase 1 Cohort 5: Participants were administered 180 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 220 mg/m^2
n=6 Participants
Phase 1 Cohort 6: Participants were administered 220 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 270 mg/m^2
n=7 Participants
Phase 1 Cohort 7: Participants were administered 270 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
Phase 2a Expansion: AVID100 220 mg/m^2
n=25 Participants
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
43 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 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
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=24 Participants
|
1 Participants
n=42 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
38 Participants
n=42 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
47 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
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
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)Any of the following toxicities, if judged to be associated with study, were considered a DLT: 1. Evidence of pulmonary fibrosis 2. G3 non-hematologic toxicity regardless of duration with the exceptions of: * G3 nausea, vomiting, diarrhea, or fatigue lasting \< 2 days * G3 asymptomatic electrolyte abnormalities lasting \< 3 days not considered clinically relevant 3. AST and/or ALT elevation \> 3 x ULN with total bilirubin \> 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors 4. Any G4 non-hematologic toxicity with the exception of: • G4 asymptomatic electrolyte abnormalities lasting \< 7 days not considered clinically significant 5. Neutropenia that is: * \> G3 and associated with fever * G4 and sustained (ANC \< 500 per mm3, duration \> 5 days) 6. Thrombocytopenia that is: * G3 with clinically significant hemorrhage or requirement for transfusion * G4 (platelets \< 25,000 per mm3) 7. Inability to complete Cycle 1 at the assigned dose
Outcome measures
| Measure |
Dose Escalation Phase 1-Cohort 1
n=1 Participants
1 Patient treated at 20mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 2
n=1 Participants
1 Patient treated at 40mg/m2, AVID100 IV is administered IV once every 3 weeks
|
Dose Escalation Phase 1-Cohort 3
n=3 Participants
3 Patients treated at 80mg/m2, AVID100 IV administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 4
n=3 Participants
3 Patients treated at 120mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 5
n=3 Participants
3 Patients treated at 180mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 6
n=6 Participants
6 Patients treated at 220 mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 7
n=7 Participants
7 Patients treated at 270mg/m2, AVID100 IV is administered once every 3 weeks
|
Phase 2a Expansion: AVID100 220 mg/m^2
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Imaging for Disease status (tumour measurements) occurred after every even cycle for the full duration of treatment and at EOT visit up to approximately 24 weeks totalPopulation: Patients who completed Cycle 2 (6 weeks) of treatment, received at least 2 planned doses during that period, and had a follow-up assessment of disease status were considered evaluable for assessment of antineoplastic activity. Patients who were withdrawn from the study before completion of Cycle 2 because of progressive disease also were included in assessments of antineoplastic activity.
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to \< 10 mm.
Outcome measures
| Measure |
Dose Escalation Phase 1-Cohort 1
n=24 Participants
1 Patient treated at 20mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 2
1 Patient treated at 40mg/m2, AVID100 IV is administered IV once every 3 weeks
|
Dose Escalation Phase 1-Cohort 3
3 Patients treated at 80mg/m2, AVID100 IV administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 4
3 Patients treated at 120mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 5
3 Patients treated at 180mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 6
6 Patients treated at 220 mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 7
7 Patients treated at 270mg/m2, AVID100 IV is administered once every 3 weeks
|
Phase 2a Expansion: AVID100 220 mg/m^2
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1
Progressive Disease
|
23 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1
Stable Disease
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1
Complete Response
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Profile (ie the first 3 weeks of dosing)Population: Patients who have completed Cycle 1 for which PK analysis was performed
Characterization of the pharmacokinetic profile of total antibody
Outcome measures
| Measure |
Dose Escalation Phase 1-Cohort 1
n=1 Participants
1 Patient treated at 20mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 2
n=1 Participants
1 Patient treated at 40mg/m2, AVID100 IV is administered IV once every 3 weeks
|
Dose Escalation Phase 1-Cohort 3
n=3 Participants
3 Patients treated at 80mg/m2, AVID100 IV administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 4
n=3 Participants
3 Patients treated at 120mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 5
n=3 Participants
3 Patients treated at 180mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 6
n=6 Participants
6 Patients treated at 220 mg/m2, AVID100 IV is administered once every 3 weeks
|
Dose Escalation Phase 1-Cohort 7
n=7 Participants
7 Patients treated at 270mg/m2, AVID100 IV is administered once every 3 weeks
|
Phase 2a Expansion: AVID100 220 mg/m^2
n=9 Participants
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment.
|
|---|---|---|---|---|---|---|---|---|
|
PK Profile of Total Antibody
Cycle 1 D2
|
3217.6 ng/mL
|
9390.7 ng/mL
|
25236.4 ng/mL
Standard Deviation 2159.3
|
43504.6 ng/mL
Standard Deviation 5940.3
|
63001.5 ng/mL
Standard Deviation 5837.3
|
68284.5 ng/mL
Standard Deviation 6605.4
|
99382.8 ng/mL
Standard Deviation 13832.9
|
NA ng/mL
Standard Deviation NA
Timepoint not assessed in Phase 2a expansion
|
|
PK Profile of Total Antibody
Cycle 1 D4
|
876.3 ng/mL
|
4578.3 ng/mL
|
14638.5 ng/mL
Standard Deviation 1776.9
|
24985.3 ng/mL
Standard Deviation 6859.7
|
35500.0 ng/mL
Standard Deviation 5004.5
|
38068.0 ng/mL
Standard Deviation 7890.3
|
69578.4 ng/mL
Standard Deviation 10616.0
|
NA ng/mL
Standard Deviation NA
Timepoint not assessed in Phase 2a expansion
|
|
PK Profile of Total Antibody
Cycle 1 D1 prior SOI
|
NA ng/mL
BLQ (below detection limit)
|
NA ng/mL
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
|
PK Profile of Total Antibody
Cycle D1 EOI
|
9213.3 ng/mL
|
13686.7 ng/mL
|
41140.7 ng/mL
Standard Deviation 7472.0
|
71440.9 ng/mL
Standard Deviation 9107.3
|
85982.9 ng/mL
Standard Deviation 8517.2
|
113401.6 ng/mL
Standard Deviation 18740.3
|
136306.3 ng/mL
Standard Deviation 16938.5
|
122464.3 ng/mL
Standard Deviation 20790.1
|
|
PK Profile of Total Antibody
Cycle 1 D1 2h post SOI
|
8066.3 ng/mL
|
14003.5 ng/mL
|
36935.8 ng/mL
Standard Deviation 7089.3
|
66587.4 ng/mL
Standard Deviation 6199.4
|
89676.6 ng/mL
Standard Deviation 6216.5
|
112663.3 ng/mL
Standard Deviation 21616.7
|
131267.2 ng/mL
Standard Deviation 10585.7
|
NA ng/mL
Standard Deviation NA
Timepoint not assessed in Phase 2a expansion
|
|
PK Profile of Total Antibody
Cycle 1 D1 4h post SOI
|
8351.9 ng/mL
|
14555.1 ng/mL
|
34399.7 ng/mL
Standard Deviation 5940.6
|
61468.6 ng/mL
Standard Deviation 4879.1
|
79581.1 ng/mL
Standard Deviation 9542.3
|
101809.1 ng/mL
Standard Deviation 17330.1
|
132671.4 ng/mL
Standard Deviation 13243.3
|
NA ng/mL
Standard Deviation NA
Timepoint not assessed in Phase 2a expansion
|
|
PK Profile of Total Antibody
Cycle 1 D8
|
NA ng/mL
BLQ (below detection limit)
|
NA ng/mL
BLQ (below detection limit)
|
2450.7 ng/mL
Standard Deviation 1422.7
|
8768.0 ng/mL
Standard Deviation 5393.1
|
12590.0 ng/mL
Standard Deviation 1531.9
|
18581.5 ng/mL
Standard Deviation 3128.7
|
27982.5 ng/mL
Standard Deviation 13531.7
|
NA ng/mL
Standard Deviation NA
Timepoint not assessed in Phase 2a expansion
|
|
PK Profile of Total Antibody
Cycle 2 D1 prior to SOI
|
NA ng/mL
BLQ (below detection limit)
|
NA ng/mL
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
NA ng/mL
Standard Deviation NA
BLQ (below detection limit)
|
866.5 ng/mL
Standard Deviation 855.8
|
131.1 ng/mL
Standard Deviation 40.6
|
Adverse Events
AVID100 20 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AVID100 40 mg/m^2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
AVID100 80 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
AVID100 120 mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
AVID100 180 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
AVID100 220 mg/m^2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
AVID100 270 mg/m^2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 2a Expansion: AVID100 220 mg/m^2
Serious events: 13 serious events
Other events: 25 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
AVID100 20 mg/m^2
n=1 participants at risk
Phase 1 Cohort 1: Participants were administered 20 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 40 mg/m^2
n=1 participants at risk
Phase 1 Cohort 1: Participants were administered 40 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 80 mg/m^2
n=3 participants at risk
Phase 1 Cohort 1: Participants were administered 80 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 120 mg/m^2
n=3 participants at risk
Phase 1 Cohort 1: Participants were administered 120 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 180 mg/m^2
n=3 participants at risk
Phase 1 Cohort 1: Participants were administered 180 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 220 mg/m^2
n=6 participants at risk
Phase 1 Cohort 1: Participants were administered 220 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 270 mg/m^2
n=7 participants at risk
Phase 1 Cohort 1: Participants were administered 270 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
Phase 2a Expansion: AVID100 220 mg/m^2
n=25 participants at risk
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Progression of Disease
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Infections and infestations
Influenza A
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Vascular disorders
Hypertension Crisis
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Gastrointestinal disorders
Upper GI Hemorrhage
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Immune system disorders
Infusion related reaction
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Dysphasia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Renal and urinary disorders
Urinary tract Obstruction
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Cardiac disorders
Super Ventricular Tachycardia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Vascular disorders
Subdural hemorrhages
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Hepatobiliary disorders
AST increased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Hepatobiliary disorders
ALT increased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Infections and infestations
Mucositis
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Uncontrolled pain
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Flu like symptoms
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Blood and lymphatic system disorders
Platelet decrease
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath with hypoxia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Creatine Kinase increase
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Infections and infestations
Multifocal pneumonia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Malignant neoplasm progression
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Elevated AST
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
Other adverse events
| Measure |
AVID100 20 mg/m^2
n=1 participants at risk
Phase 1 Cohort 1: Participants were administered 20 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 40 mg/m^2
n=1 participants at risk
Phase 1 Cohort 1: Participants were administered 40 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 80 mg/m^2
n=3 participants at risk
Phase 1 Cohort 1: Participants were administered 80 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 120 mg/m^2
n=3 participants at risk
Phase 1 Cohort 1: Participants were administered 120 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 180 mg/m^2
n=3 participants at risk
Phase 1 Cohort 1: Participants were administered 180 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 220 mg/m^2
n=6 participants at risk
Phase 1 Cohort 1: Participants were administered 220 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
AVID100 270 mg/m^2
n=7 participants at risk
Phase 1 Cohort 1: Participants were administered 270 mg/m\^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.
|
Phase 2a Expansion: AVID100 220 mg/m^2
n=25 participants at risk
Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg/m\^2 administered every 3 weeks IV, for at least 1 cycle. Extended treatment was permitted for participants tolerating and benefiting from treatment.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
66.7%
2/3 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
2/6 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
57.1%
4/7 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
32.0%
8/25 • Number of events 8 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
24.0%
6/25 • Number of events 6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Eye disorders
Dry Eye
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
28.6%
2/7 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
2/6 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Eye disorders
Keratitis
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
2/6 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.0%
4/25 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
20.0%
5/25 • Number of events 5 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Blood Alkaline Phosphate Increased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.0%
4/25 • Number of events 6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
66.7%
2/3 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Lipase Increased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
28.6%
2/7 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
100.0%
1/1 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
28.6%
2/7 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
66.7%
2/3 • Number of events 5 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
20.0%
5/25 • Number of events 12 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
42.9%
3/7 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
28.6%
2/7 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
24.0%
6/25 • Number of events 13 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
66.7%
2/3 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
66.7%
2/3 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.0%
4/25 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
100.0%
1/1 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
66.7%
2/3 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
28.6%
2/7 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
24.0%
6/25 • Number of events 7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
57.1%
4/7 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
48.0%
12/25 • Number of events 16 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneform
|
100.0%
1/1 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
66.7%
2/3 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
66.7%
4/6 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
42.9%
3/7 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
12.0%
3/25 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.0%
4/25 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
24.0%
6/25 • Number of events 6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
20.0%
5/25 • Number of events 7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Hyperuricaemia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 4 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Psychiatric disorders
Insomnia
|
100.0%
1/1 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Dysphagia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Face Oedema
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Pain
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/7 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
4.0%
1/25 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
Investigations
Alkaline Phosphatase Increase
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
16.7%
1/6 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
14.3%
1/7 • Number of events 1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
|
General disorders
Anorexia
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/1 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
33.3%
1/3 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/3 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/6 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
28.6%
2/7 • Number of events 2 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
0.00%
0/25 • Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved up to approximately 28 weeks total.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place