Trial Outcomes & Findings for Immunotherapy Study for Patients With Stage IV Melanoma (NCT NCT02054520)
NCT ID: NCT02054520
Last Updated: 2023-04-18
Results Overview
To determine the safety of administration of immune checkpoint inhibition consisting of ipilimumab, nivolumab, or pembrolizumab with or without dorgenmeltucel-L immunotherapy for patients with stage IV melanoma
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
2 years
Results posted on
2023-04-18
Participant Flow
The enrollment and treatment phase of this trial was terminated early, but the FDA required 15 year long term follow-up for gene therapy is still ongoing.
Participant milestones
| Measure |
Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Ipilimumab
|
Arm 2A Ipilimumab Alone
Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
Ipilimumab
|
Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab
Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Nivolumab
|
Arm 2B Nivolumab Alone
Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
Nivolumab
|
Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab
Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Pembrolizumab
|
Arm 2C Pembrolizumab Alone
Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks
Pembrolizumab
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
16
|
6
|
6
|
5
|
3
|
|
Overall Study
COMPLETED
|
2
|
11
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
6
|
6
|
5
|
3
|
Reasons for withdrawal
| Measure |
Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Ipilimumab
|
Arm 2A Ipilimumab Alone
Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
Ipilimumab
|
Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab
Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Nivolumab
|
Arm 2B Nivolumab Alone
Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
Nivolumab
|
Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab
Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Pembrolizumab
|
Arm 2C Pembrolizumab Alone
Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks
Pembrolizumab
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
2
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
0
|
2
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Study terminated by Sponsor
|
0
|
0
|
2
|
1
|
0
|
0
|
Baseline Characteristics
Immunotherapy Study for Patients With Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
n=11 Participants
Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Ipilimumab
|
Arm 2A Ipilimumab Alone
n=16 Participants
Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
Ipilimumab
|
Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab
n=6 Participants
Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Nivolumab
|
Arm 2B Nivolumab Alone
n=6 Participants
Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
Nivolumab
|
Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab
n=5 Participants
Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Pembrolizumab
|
Arm 2C Pembrolizumab Alone
n=3 Participants
Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks
Pembrolizumab
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
63.4 years
n=7 Participants
|
61.3 years
n=5 Participants
|
67.5 years
n=4 Participants
|
60.8 years
n=21 Participants
|
62.3 years
n=8 Participants
|
62.4 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
30 Participants
n=8 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
47 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
47 Participants
n=8 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
ECOG Performance Status
ECOG PS Score 0
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
ECOG Performance Status
ECOG PS Score 1
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The primary population for safety analyses is the safety analysis set, defined as all randomized subjects who receive at least one administration of study treatment (dorgenmeltucel-L or immune checkpoint therapy).
To determine the safety of administration of immune checkpoint inhibition consisting of ipilimumab, nivolumab, or pembrolizumab with or without dorgenmeltucel-L immunotherapy for patients with stage IV melanoma
Outcome measures
| Measure |
Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
n=11 Participants
Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Ipilimumab
|
Arm 2A Ipilimumab Alone
n=16 Participants
Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
Ipilimumab
|
Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab
n=6 Participants
Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Nivolumab
|
Arm 2B Nivolumab Alone
n=6 Participants
Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
Nivolumab
|
Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab
n=5 Participants
Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Pembrolizumab
|
Arm 2C Pembrolizumab Alone
n=3 Participants
Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks
Pembrolizumab
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters
At least one TEAE
|
11 participants with event
|
16 participants with event
|
6 participants with event
|
5 participants with event
|
5 participants with event
|
3 participants with event
|
|
Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters
At least one Serious TEAE
|
3 participants with event
|
3 participants with event
|
1 participants with event
|
2 participants with event
|
0 participants with event
|
2 participants with event
|
|
Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters
At least one DLT
|
0 participants with event
|
0 participants with event
|
0 participants with event
|
0 participants with event
|
0 participants with event
|
0 participants with event
|
|
Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters
At least one severe TEAE
|
7 participants with event
|
6 participants with event
|
4 participants with event
|
2 participants with event
|
1 participants with event
|
1 participants with event
|
|
Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters
At least one related TEAE
|
11 participants with event
|
0 participants with event
|
6 participants with event
|
0 participants with event
|
5 participants with event
|
0 participants with event
|
|
Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters
At least one TEAE leading to discontinuation
|
1 participants with event
|
4 participants with event
|
2 participants with event
|
1 participants with event
|
1 participants with event
|
0 participants with event
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The enrollment and treatment phase of this trial was terminated early. The analysis of clinical response rate was limited as enrollment to the trial was closed early.
To estimate the clinical response rate of metastatic melanoma patients after immunotherapy with dorgenmeltucel-L immunotherapy plus immune checkpoint inhibition
Outcome measures
| Measure |
Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
n=8 Participants
Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Ipilimumab
|
Arm 2A Ipilimumab Alone
n=14 Participants
Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
Ipilimumab
|
Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab
n=4 Participants
Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Nivolumab
|
Arm 2B Nivolumab Alone
n=2 Participants
Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
Nivolumab
|
Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab
n=4 Participants
Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Pembrolizumab
|
Arm 2C Pembrolizumab Alone
n=3 Participants
Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks
Pembrolizumab
|
|---|---|---|---|---|---|---|
|
Clinical Response Rate
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
Serious events: 3 serious events
Other events: 11 other events
Deaths: 5 deaths
Arm 2A Ipilimumab Alone
Serious events: 3 serious events
Other events: 16 other events
Deaths: 7 deaths
Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Arm 2B Nivolumab Alone
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Arm 2C Pembrolizumab Alone
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
n=11 participants at risk
Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Ipilimumab
|
Arm 2A Ipilimumab Alone
n=16 participants at risk
Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
Ipilimumab
|
Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab
n=6 participants at risk
Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Nivolumab
|
Arm 2B Nivolumab Alone
n=6 participants at risk
Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
Nivolumab
|
Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab
n=5 participants at risk
Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Pembrolizumab
|
Arm 2C Pembrolizumab Alone
n=3 participants at risk
Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks
Pembrolizumab
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Immune system disorders
Hypersensitivity
|
9.1%
1/11 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
Other adverse events
| Measure |
Arm 1A HyperAcute®-Melanoma (HAM) + Ipilimumab
n=11 participants at risk
Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Ipilimumab
|
Arm 2A Ipilimumab Alone
n=16 participants at risk
Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
Ipilimumab
|
Arm 1B HyperAcute®-Melanoma (HAM) + Nivolumab
n=6 participants at risk
Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Nivolumab
|
Arm 2B Nivolumab Alone
n=6 participants at risk
Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
Nivolumab
|
Arm 1C HyperAcute®-Melanoma (HAM) + Pembrolizumab
n=5 participants at risk
Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
HyperAcute®-Melanoma (HAM) Immunotherapy
Pembrolizumab
|
Arm 2C Pembrolizumab Alone
n=3 participants at risk
Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks
Pembrolizumab
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
40.0%
2/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Cardiac disorders
Bradycardia
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Cardiac disorders
Palpitations
|
18.2%
2/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Ear and labyrinth disorders
Ear Haemorrhage
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Ear and labyrinth disorders
Middle Ear Inflammation
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Endocrine disorders
Hypopituitarism
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Eye disorders
Diplopia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Eye disorders
Watering Eyes
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Abdominal distention
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
25.0%
4/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
45.5%
5/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
25.0%
4/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
50.0%
3/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
enterocolitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Gastoesophaeal Reflux Disease
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
81.8%
9/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
18.8%
3/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
66.7%
4/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
66.7%
4/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
40.0%
2/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
83.3%
5/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
50.0%
3/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Asthenia
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Chest pain
|
18.2%
2/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Chills
|
45.5%
5/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Fatigue
|
81.8%
9/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
43.8%
7/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
83.3%
5/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
50.0%
3/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
100.0%
5/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
66.7%
2/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Inflammation
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Influenza like illness
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Injection site erythema
|
100.0%
11/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
100.0%
6/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
80.0%
4/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Injection site induration
|
81.8%
9/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
66.7%
4/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
100.0%
5/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Injection site irritation
|
36.4%
4/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
80.0%
4/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Injection site pain
|
81.8%
9/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
83.3%
5/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Injection site Pruritus
|
72.7%
8/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
100.0%
6/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
40.0%
2/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Injection Site Reaction
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Injection site swelling
|
100.0%
11/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
83.3%
5/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
80.0%
4/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Injection site warmth
|
54.5%
6/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
66.7%
4/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Malaise
|
27.3%
3/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Mucosal Inflammation
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Oedema
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
General disorders
Pyrexia
|
36.4%
4/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
18.8%
3/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Immune system disorders
Hypersensitivity
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Rhinitis
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.2%
2/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Aspartate Aminostransferase Increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
18.8%
3/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
66.7%
4/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Blood immunoglobulin E increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Blood immunoglobulin G increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Cortisol increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
C-reactive protein Increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Thyroxine increased
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Weight Decreased
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Investigations
Weight Increased
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
45.5%
5/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
50.0%
3/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
27.3%
3/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
50.0%
3/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
18.2%
2/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
18.8%
3/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
2/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck Mass
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
50.0%
3/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
disturbance in attention
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Dizziness
|
45.5%
5/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
25.0%
4/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
50.0%
3/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Headache
|
36.4%
4/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
25.0%
4/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
83.3%
5/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
40.0%
2/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Hypoaesthesia
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Migraine
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Tinnitus
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Psychiatric disorders
agitation
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Psychiatric disorders
Insomnia
|
27.3%
3/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
25.0%
4/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Psychiatric disorders
Libido decreased
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Reproductive system and breast disorders
Breast Discharge
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
40.0%
2/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
40.0%
2/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
paranasal sinus discomfort
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
3/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
62.5%
10/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
66.7%
4/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
2/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
25.0%
4/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
2/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
20.0%
1/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Skin and subcutaneous tissue disorders
Yellow Skin
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Vascular disorders
deep Vein Thrombosis
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Vascular disorders
Embolism
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
12.5%
2/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
16.7%
1/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
6.2%
1/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/11 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/16 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
0.00%
0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
33.3%
1/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
|
Additional Information
Manager, Clinical Operations
NewLink Genetics Corporation
Phone: 515-598-5020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60