Trial Outcomes & Findings for Clinical Study of WT2725 in Patients With Advanced Malignancies (NCT NCT01621542)
NCT ID: NCT01621542
Last Updated: 2019-07-17
Results Overview
Evaluation of the safety and tolerability of WT2725 Dosing Emulsion based on the occurrence of DLT and AEs The safety and tolerability of WT2725 Dosing Emulsion will be evaluated based on the occurrence of DLT and AEs, and the findings from clinical laboratory tests, vital signs measurements, body weight measurements, and electrocardiogram (ECG) results. The incidence of DLT will be evaluated during the DLT Evaluation Period, which extends from the day of the first dose to just prior to the fifth dose of study drug (Days 1 to 29). No more than 4 doses of study drug will be administered during the DLT Evaluation Period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2019-07-17
Participant Flow
please note that there were two subjects that never received study drug medication
Participant milestones
| Measure |
WT2725 0.3 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 0.9 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 3.0 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 9 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 18 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 27 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
6
|
28
|
9
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
6
|
28
|
9
|
9
|
Reasons for withdrawal
| Measure |
WT2725 0.3 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 0.9 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 3.0 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 9 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 18 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 27 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
3
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
13
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
3
|
3
|
3
|
|
Overall Study
progression/treatment failure
|
2
|
4
|
3
|
7
|
3
|
5
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
study stopped by sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Clinical Study of WT2725 in Patients With Advanced Malignancies
Baseline characteristics by cohort
| Measure |
WT2725 0.3 mg
n=5 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 0.9 mg
n=5 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 3.0 mg
n=6 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 9 mg
n=28 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 18 mg
n=9 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 27 mg
n=9 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
38 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 8.96 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 7.99 • n=107 Participants
|
63.0 years
STANDARD_DEVIATION 9.25 • n=206 Participants
|
57.5 years
STANDARD_DEVIATION 15.46 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 16.14 • n=31 Participants
|
59.4 years
STANDARD_DEVIATION 15.83 • n=30 Participants
|
58.0 years
STANDARD_DEVIATION 14.17 • n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
33 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
29 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
57 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
53 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
62 Participants
n=3 Participants
|
|
ECOG Performance Status [n(%)] The Eastern Cooperative Oncology Group (ECOG) score
0
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
|
ECOG Performance Status [n(%)] The Eastern Cooperative Oncology Group (ECOG) score
1
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
36 Participants
n=3 Participants
|
|
ECOG Performance Status [n(%)] The Eastern Cooperative Oncology Group (ECOG) score
2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
ECOG Performance Status [n(%)] The Eastern Cooperative Oncology Group (ECOG) score
3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
ECOG Performance Status [n(%)] The Eastern Cooperative Oncology Group (ECOG) score
4
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsPopulation: Safety Population (defined as all enrolled patients who received at least one dose of study drug.)
Evaluation of the safety and tolerability of WT2725 Dosing Emulsion based on the occurrence of DLT and AEs The safety and tolerability of WT2725 Dosing Emulsion will be evaluated based on the occurrence of DLT and AEs, and the findings from clinical laboratory tests, vital signs measurements, body weight measurements, and electrocardiogram (ECG) results. The incidence of DLT will be evaluated during the DLT Evaluation Period, which extends from the day of the first dose to just prior to the fifth dose of study drug (Days 1 to 29). No more than 4 doses of study drug will be administered during the DLT Evaluation Period.
Outcome measures
| Measure |
WT2725 0.3 mg
n=5 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 0.9 mg
n=5 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 3.0 mg
n=6 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 9 mg
n=28 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 18 mg
n=9 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 27 mg
n=9 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
|---|---|---|---|---|---|---|
|
Occurrence of Dose-limiting Toxicities and Adverse Events
|
0 number of occurances
|
0 number of occurances
|
0 number of occurances
|
0 number of occurances
|
0 number of occurances
|
0 number of occurances
|
PRIMARY outcome
Timeframe: Day 1 - Day 29Population: Safety Population (defined as all enrolled patients who received at least one dose of study drug.)
Outcome measures
| Measure |
WT2725 0.3 mg
n=5 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 0.9 mg
n=5 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 3.0 mg
n=6 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 9 mg
n=28 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 18 mg
n=9 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 27 mg
n=9 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of WT2725 Based on the Evaluation of Dose-limiting Toxicity (DLT)
|
0 Dose Limiting Toxicity
|
0 Dose Limiting Toxicity
|
0 Dose Limiting Toxicity
|
0 Dose Limiting Toxicity
|
0 Dose Limiting Toxicity
|
0 Dose Limiting Toxicity
|
SECONDARY outcome
Timeframe: Day 1 - within 28 days after last dosePopulation: Efficacy irRC population: including all the patients in the Safety population who are not AML patients and whose lesions are measureable and have at least one posttreatment assessment.
Tumor response, as evaluated according to irRC, was based on total measurable tumor burden in patients with solid tumors (ie, non-AML patients). Tumor assessments will be conducted during screening, and then every 8 weeks after the first dose of study drug. All tumor assessments may be performed within ±7 days of the scheduled assessment. All patients should complete an End of Study visit within 28 days after the last dose of study drug and prior to the start of alternate antineoplastic therapy.
Outcome measures
| Measure |
WT2725 0.3 mg
n=4 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 0.9 mg
n=4 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 3.0 mg
n=6 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 9 mg
n=18 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 18 mg
n=3 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 27 mg
n=5 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
|---|---|---|---|---|---|---|
|
Antitumor Responses to WT2725 Based on the Immune-related Response Criteria (irRC)
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 - within 28 days after last dosePopulation: Efficacy population for modified IWG response: includes all the AML patients in the Safety population who have \>5% marrow blasts or \>50 copy/μｇRNA of quantitative RT-PCR for WT1 transcript before the first date/time of study drug and who have at least one posttreatment assessment.
The modified IWG response criteria were used to assess drug activity in AML patients. Tumor assessments will be conducted during screening, and then every 8 weeks after the first dose of study drug. All tumor assessments may be performed within ±7 days of the scheduled assessment. All patients should complete an End of Study visit within 28 days after the last dose of study drug and prior to the start of alternate antineoplastic therapy.
Outcome measures
| Measure |
WT2725 0.3 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 0.9 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 3.0 mg
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 9 mg
n=5 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 18 mg
n=3 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 27 mg
n=1 Participants
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
|---|---|---|---|---|---|---|
|
Immune Response to WT2725
|
—
|
—
|
—
|
3 participants
|
2 participants
|
0 participants
|
Adverse Events
WT2725 0.3 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WT2725 0.9 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WT2725 3.0 mg
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
WT2725 9 mg
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
WT2725 18 mg
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
WT2725 27 mg
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
WT2725 0.3 mg
n=5 participants at risk
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 0.9 mg
n=5 participants at risk
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 3.0 mg
n=6 participants at risk
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 9 mg
n=28 participants at risk
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 18 mg
n=9 participants at risk
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
WT2725 27 mg
n=9 participants at risk
WT2725; injection WT2725: WT2725 injection Study drug will be administered every 1-4 weeks
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
16.7%
1/6 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
16.7%
1/6 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Cardiac disorders
cardiac failure congestive
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Infections and infestations
Eye infection
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 2 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor necrosis
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
3.6%
1/28 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/5 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/6 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/28 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
0.00%
0/9 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
11.1%
1/9 • Number of events 1 • One month
Serious adverse events (SAEs) will be defined as: • AEs that occurred on or after the first dose of study drug and on or before the 30th day after the last dose of study drug, • AEs with a missing start date and a stop date on or after the first dose of study drug, or • AEs with both a missing start and stop date.
|
Other adverse events
Adverse event data not reported
Additional Information
WT2725 Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER