Trial Outcomes & Findings for Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema (NCT NCT00225147)
NCT ID: NCT00225147
Last Updated: 2013-02-22
Results Overview
The time to beginning of relief of symptoms at the location that showed the first visual analogue scale ("VAS") score decrease of at least 20 mm from baseline score with persistence to the next timepoint, assessment timepoints were taken on pre-scheduled time-points after study drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to beginning of relief has been calculated as median time, by using the exact timepoints on which each assessment was performed.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
77 participants
Primary outcome timeframe
up to 48 hours after study drug administration
Results posted on
2013-02-22
Participant Flow
During the double-blind phase of the study, patients were randomized once to receive 100 IU/kg "rhC1INH", 50 IU/kg "rhC1INH" or Saline in a ratio of 1:1:1. After treatment in the double-blind phase, patients with subsequent eligible attacks could be treated with open-label 50 IU/kg "rhC1INH".
Patients could be enrolled into the open-label phase of the study after treatment in the double-blind phase of the study, including those enrolled but not treated in the double-blind phase.
Participant milestones
| Measure |
100 IU/kg "rhC1INH"
Includes all subjects randomized and treated with 100 IU/kg Recombinant human C1 inhibitor in the double-blind phase
|
50 IU/kg "rhC1INH"
Includes all subjects randomized and treated with 50 IU/kg Recombinant human C1 inhibitor in the double-blind phase
|
Placebo
Includes all subjects randomized and treated with Placebo in the double-blind phase
|
50 IU/kg Open-label "rhC1INH"
Includes all subjects treated with 50 IU/kg open-label "rhC1INH" in the open-label phase.
|
|---|---|---|---|---|
|
Double-blind Phase
STARTED
|
13
|
12
|
13
|
0
|
|
Double-blind Phase
COMPLETED
|
13
|
12
|
13
|
0
|
|
Double-blind Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Open-label Phase
STARTED
|
0
|
0
|
0
|
62
|
|
Open-label Phase
COMPLETED
|
0
|
0
|
0
|
52
|
|
Open-label Phase
NOT COMPLETED
|
0
|
0
|
0
|
10
|
Reasons for withdrawal
| Measure |
100 IU/kg "rhC1INH"
Includes all subjects randomized and treated with 100 IU/kg Recombinant human C1 inhibitor in the double-blind phase
|
50 IU/kg "rhC1INH"
Includes all subjects randomized and treated with 50 IU/kg Recombinant human C1 inhibitor in the double-blind phase
|
Placebo
Includes all subjects randomized and treated with Placebo in the double-blind phase
|
50 IU/kg Open-label "rhC1INH"
Includes all subjects treated with 50 IU/kg open-label "rhC1INH" in the open-label phase.
|
|---|---|---|---|---|
|
Open-label Phase
Lost to Follow-up
|
0
|
0
|
0
|
4
|
|
Open-label Phase
Withdrawal by Subject
|
0
|
0
|
0
|
6
|
Baseline Characteristics
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Baseline characteristics by cohort
| Measure |
100 IU/kg "rhC1INH"
n=13 Participants
Baseline characteristics were calculated for the modified intention to treat ("mITT") and per protocol analysis populations, which included all subjects who received 100 IU/kg "rhC1INH".
|
50 IU/kg "rhC1INH"
n=12 Participants
Baseline characteristics were calculated for the modified intention to treat ("mITT") and per protocol analysis populations, which included subjects who received 50 IU/kg "rhC1INH". One (1) subject was randomized to the 50 IU/kg "rhC1INH" arm, but did not receive study drug administration and was excluded from the "mITT" analysis population.
|
Placebo
n=13 Participants
Baseline characteristics were calculated for the modified intention to treat ("mITT") analysis population, which included all subjects randomized to the placebo arm.
|
50 IU/kg Open-label "rhC1INH"
n=39 Participants
Baseline characteristics were calculated for the modified intention to treat ("mITT")analysis population, which included all subjects who received 50 IU/kg open-label "rhC1INH".
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 48 hours after study drug administrationPopulation: The full analysis set ("FAS" or "mITT") was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration.
The time to beginning of relief of symptoms at the location that showed the first visual analogue scale ("VAS") score decrease of at least 20 mm from baseline score with persistence to the next timepoint, assessment timepoints were taken on pre-scheduled time-points after study drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to beginning of relief has been calculated as median time, by using the exact timepoints on which each assessment was performed.
Outcome measures
| Measure |
100 IU/kg "rhC1INH"
n=13 Participants
Includes all subjects enrolled and randomized to the 100 IU/kg body weight recombinant human C1 Inhibitor arm
|
50 IU/kg "rhC1INH"
n=12 Participants
Includes all subjects enrolled and randomized to the 50 IU/kg body weight recombinant human C1 Inhibitor arm
|
Placebo
n=13 Participants
Includes all subjects enrolled and randomized to the Saline arm
|
50 IU/kg Open-label "rhC1INH"
n=62 Participants
Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
|
|---|---|---|---|---|
|
Time to Beginning of Relief of Symptoms
|
68 minutes
Interval 55.0 to 285.0
|
122 minutes
Interval 29.0 to 250.0
|
258 minutes
Interval 30.0 to 721.0
|
62.5 minutes
Interval 15.0 to 1499.0
|
SECONDARY outcome
Timeframe: up to 48 hours after study drug administrationPopulation: The full analysis set ("FAS" or "mITT") was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration.
The time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale ("VAS") score. Symptoms were said to be minimal when the "VAS" score at all locations was below 20 mm. Assessment timepoints were: baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to minimal symtoms has been calculated by using the exact timepoints on which each assessment was performed.
Outcome measures
| Measure |
100 IU/kg "rhC1INH"
n=13 Participants
Includes all subjects enrolled and randomized to the 100 IU/kg body weight recombinant human C1 Inhibitor arm
|
50 IU/kg "rhC1INH"
n=12 Participants
Includes all subjects enrolled and randomized to the 50 IU/kg body weight recombinant human C1 Inhibitor arm
|
Placebo
n=13 Participants
Includes all subjects enrolled and randomized to the Saline arm
|
50 IU/kg Open-label "rhC1INH"
n=62 Participants
Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
|
|---|---|---|---|---|
|
Time to Minimal Symptoms
|
245 minutes
Interval 125.0 to 270.0
|
246.5 minutes
Interval 243.0 to 484.0
|
1101 minutes
Interval 970.0 to 1494.0
|
145 minutes
Interval 124.0 to 256.0
|
Adverse Events
100 IU/kg rhC1INH
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
50 IU/kg rhC1INH
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 IU/kg Open-label "rhC1INH"
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 IU/kg rhC1INH
n=13 participants at risk
Includes all subjects receiving 100 IU/kg Recombinant human C1 inhibitor
|
50 IU/kg rhC1INH
n=12 participants at risk
Includes all subjects receiving 50 IU/kg Recombinant human C1 inhibitor
|
Placebo
n=13 participants at risk
Includes all subjects receiving Saline solution
|
50 IU/kg Open-label "rhC1INH"
n=62 participants at risk
Includes all subjects receiving 50 IU/kg open-label recombinant human C1 inhibitor and subjects receiving an additional dose of 50 IU/kg "rhC1INH" within 4 hours after initial administration.
|
|---|---|---|---|---|
|
Infections and infestations
pneumonia - severe
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
1.6%
1/62 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Infections and infestations
escherichia sepsis
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
1.6%
1/62 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Nervous system disorders
vertigo - severe
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
1.6%
1/62 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
1.6%
1/62 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
Other adverse events
| Measure |
100 IU/kg rhC1INH
n=13 participants at risk
Includes all subjects receiving 100 IU/kg Recombinant human C1 inhibitor
|
50 IU/kg rhC1INH
n=12 participants at risk
Includes all subjects receiving 50 IU/kg Recombinant human C1 inhibitor
|
Placebo
n=13 participants at risk
Includes all subjects receiving Saline solution
|
50 IU/kg Open-label "rhC1INH"
n=62 participants at risk
Includes all subjects receiving 50 IU/kg open-label recombinant human C1 inhibitor and subjects receiving an additional dose of 50 IU/kg "rhC1INH" within 4 hours after initial administration.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
8.3%
1/12 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/62 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Nervous system disorders
headache
|
15.4%
2/13 • Number of events 2 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
19.4%
12/62 • Number of events 23 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
General disorders
injection site swelling
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
7.7%
1/13 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/62 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
7.7%
1/13 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/62 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Skin and subcutaneous tissue disorders
rash erythematous
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
7.7%
1/13 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/62 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
7.7%
1/13 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/62 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Nervous system disorders
vertigo
|
7.7%
1/13 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
3.2%
2/62 • Number of events 2 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
4.8%
3/62 • Number of events 3 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
3.2%
2/62 • Number of events 3 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
8.3%
1/12 • Number of events 1 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/62 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Respiratory, thoracic and mediastinal disorders
sinusitis
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
3.2%
2/62 • Number of events 2 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
General disorders
fatigue
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
3.2%
2/62 • Number of events 2 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/12 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
0.00%
0/13 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
3.2%
2/62 • Number of events 3 • Treatment-Emergent-Adverse-Events (TEAEs) were defined as events with start from onset of study drug administration. Serious Adverse events and Adverse events for each arm with onset dates within 7 days of study drug administration have been listed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator must provide a copy of any results communication to the sponsor for review at least 30 days prior to its submission or disclosure. The sponsor may request to delete information identified by sponsor as confidential information prior to submitting such manuscript and/or abstract for publication. For a multi-center study, the investigator must wait (i) at least 24 months after the study is completed at all sites or (ii) until after the multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER