Trial Outcomes & Findings for Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia (NCT NCT05184764)
NCT ID: NCT05184764
Last Updated: 2026-03-23
Results Overview
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0. Per SAP, all patients with uncomplicated SAB (Phase 1 Cohort 1 and Cohort 2) will be combined.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
AP-SA02 Phase 1 Cohort 1 Uncomplicated
Anti-staphylococcal bacteriophage
AP-SA02: Bacteriophage administered via intravenous bolus infusion
Dose: 2 x 10\^9
|
Placebo Phase 1 Cohort 1 Uncomplicated
Inactive Isotonic Saline Solution
Placebo: Inactive Placebo administered via intravenous bolus infusion
|
AP-SA02 Phase 1 Cohort 2 Uncomplicated
Anti-staphylococcal bacteriophage
AP-SA02: Bacteriophage administered via intravenous bolus infusion
Dose: 2 x 10\^ 10
|
Placebo Phase 1 Cohort 2 Uncomplicated
Inactive Isotonic Saline Solution
Placebo: Inactive Placebo administered via intravenous bolus infusion
|
AP-SA02 Phase 2 Complicated
Anti-staphylococcal bacteriophage
AP-SA02: Bacteriophage administered via intravenous bolus infusion
Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
Inactive Isotonic Saline Solution
Placebo: Inactive Placebo administered via intravenous bolus infusion
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
3
|
1
|
31
|
16
|
|
Overall Study
COMPLETED
|
2
|
1
|
3
|
1
|
21
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
Baseline characteristics by cohort
| Measure |
AP-SA02 Phase 1 Cohort 2 Uncomplicated
n=3 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10\^ 10
|
Total
n=56 Participants
Total of all reporting groups
|
AP-SA02 Phase 2 Complicated
n=31 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=16 Participants
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Placebo Phase 1 Cohort 1 Uncomplicated
n=1 Participants
Inactive Isotonic Saline Solution
Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Placebo Phase 1 Cohort 2 Uncomplicated
n=1 Participants
Inactive Isotonic Saline Solution
Placebo: Inactive Placebo administered via intravenous bolus infusion
|
AP-SA02 Phase 1 Cohort 1 Uncomplicated
n=4 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10\^9
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=1 Participants
|
43 Participants
n=2 Participants
|
23 Participants
n=10 Participants
|
12 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=158 Participants
|
3 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
13 Participants
n=2 Participants
|
8 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
17 Participants
n=2 Participants
|
9 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=1 Participants
|
39 Participants
n=2 Participants
|
22 Participants
n=10 Participants
|
10 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=158 Participants
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
22 Participants
n=2 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
13 Participants
n=10 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
5 Participants
n=8 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
0 Participants
n=18 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
1 Participants
n=158 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
2 Participants
n=3 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=1 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
34 Participants
n=2 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
18 Participants
n=10 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
11 Participants
n=8 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
1 Participants
n=18 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
0 Participants
n=158 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
2 Participants
n=3 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
0 Participants
n=2 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
0 Participants
n=10 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
0 Participants
n=8 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
0 Participants
n=18 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
0 Participants
n=158 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
0 Participants
n=3 Participants • Baseline characteristics and demographics collected for all randomized patients including patients that did not dose.
|
|
Region of Enrollment
United States
|
3 participants
n=1 Participants
|
55 participants
n=2 Participants
|
30 participants
n=10 Participants
|
16 participants
n=8 Participants
|
1 participants
n=18 Participants
|
1 participants
n=158 Participants
|
4 participants
n=3 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=1 Participants
|
1 participants
n=2 Participants
|
1 participants
n=10 Participants
|
0 participants
n=8 Participants
|
0 participants
n=18 Participants
|
0 participants
n=158 Participants
|
0 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).Population: All randomized participants who received ≥ 1 dose of AP-SA02 or placebo in combination with best available antibiotic therapy (BAT).
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0. Per SAP, all patients with uncomplicated SAB (Phase 1 Cohort 1 and Cohort 2) will be combined.
Outcome measures
| Measure |
AP-SA02 Phase 2 Complicated
n=29 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=13 Participants
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Phase 1b Uncomplicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT)
n=6 Participants
Participants received AP-SA02, an intravenous (IV) bacteriophage therapy targeting Staphylococcus aureus, administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT)
n=2 Participants
Participants received placebo, consisting of the AP-SA02 formulation buffer (sterile, isotonic, pH-neutral solution), administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02.
≥ 1 TEAE n (%)
|
17 number of participants
|
10 number of participants
|
6 number of participants
|
2 number of participants
|
SECONDARY outcome
Timeframe: 12 DaysPopulation: Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).
Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.
Outcome measures
| Measure |
AP-SA02 Phase 2 Complicated
n=24 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=12 Participants
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Phase 1b Uncomplicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT)
Participants received AP-SA02, an intravenous (IV) bacteriophage therapy targeting Staphylococcus aureus, administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT)
Participants received placebo, consisting of the AP-SA02 formulation buffer (sterile, isotonic, pH-neutral solution), administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
|---|---|---|---|---|
|
Clinical Improvement or Response at Day 12
Clinical Response Assessed by the CEAC
|
20 Participants
|
7 Participants
|
—
|
—
|
|
Clinical Improvement or Response at Day 12
Clinical Response Assessed by the Investigator
|
21 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days post completion of best available antibiotic therapy, up to 60 days.Population: Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).ITT (Patients receiving at least one dose) and who completed their study visit at 7 days post BAT. This does not include patients who discontinued the study or who were LTFU.
Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.
Outcome measures
| Measure |
AP-SA02 Phase 2 Complicated
n=21 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=8 Participants
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Phase 1b Uncomplicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT)
Participants received AP-SA02, an intravenous (IV) bacteriophage therapy targeting Staphylococcus aureus, administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT)
Participants received placebo, consisting of the AP-SA02 formulation buffer (sterile, isotonic, pH-neutral solution), administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
|---|---|---|---|---|
|
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator
|
21 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days post completion of best available antibiotic therapy, up to 60 days.Population: Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).ITT (Patients receiving at least one dose) and who completed their study visit at 7 days post BAT. This does not include patients who discontinued the study or who were LTFU.
Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.
Outcome measures
| Measure |
AP-SA02 Phase 2 Complicated
n=21 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=9 Participants
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Phase 1b Uncomplicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT)
Participants received AP-SA02, an intravenous (IV) bacteriophage therapy targeting Staphylococcus aureus, administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT)
Participants received placebo, consisting of the AP-SA02 formulation buffer (sterile, isotonic, pH-neutral solution), administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
|---|---|---|---|---|
|
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC
|
21 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days post completion of best available antibiotic therapy, up to 81 days.Population: Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).ITT (Patients receiving at least one dose) and who completed their study visit at 28 days post BAT. This does not include patients who discontinued the study or who were LTFU.
Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.
Outcome measures
| Measure |
AP-SA02 Phase 2 Complicated
n=21 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=8 Participants
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Phase 1b Uncomplicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT)
Participants received AP-SA02, an intravenous (IV) bacteriophage therapy targeting Staphylococcus aureus, administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT)
Participants received placebo, consisting of the AP-SA02 formulation buffer (sterile, isotonic, pH-neutral solution), administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
|---|---|---|---|---|
|
Clinical Improvement or Response as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy
|
21 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days post completion of best available antibiotic therapy, up to 81 days.Population: Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).ITT (Patients receiving at least one dose) and who completed their study visit at 28 days post BAT. This does not include patients who discontinued the study or who were LTFU.
Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.
Outcome measures
| Measure |
AP-SA02 Phase 2 Complicated
n=20 Participants
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=8 Participants
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Phase 1b Uncomplicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT)
Participants received AP-SA02, an intravenous (IV) bacteriophage therapy targeting Staphylococcus aureus, administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT)
Participants received placebo, consisting of the AP-SA02 formulation buffer (sterile, isotonic, pH-neutral solution), administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB).
|
|---|---|---|---|---|
|
Clinical Improvement or Response as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy
|
20 Participants
|
6 Participants
|
—
|
—
|
Adverse Events
AP-SA02 Phase 2 Complicated
Serious events: 4 serious events
Other events: 19 other events
Deaths: 1 deaths
Placebo Phase 2 Complicated
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
AP-SA02 Phase 1 Cohort 1 Uncomplicated
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
AP-SA02 Phase 1 Cohort 2 Uncomplicated
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Phase 1 Cohort 1 Uncomplicated
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Phase 1 Cohort 2 Uncomplicated
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AP-SA02 Phase 2 Complicated
n=29 participants at risk
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=13 participants at risk
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
AP-SA02 Phase 1 Cohort 1 Uncomplicated
n=3 participants at risk
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10\^9
|
AP-SA02 Phase 1 Cohort 2 Uncomplicated
n=3 participants at risk
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10\^ 10
|
Placebo Phase 1 Cohort 1 Uncomplicated
n=1 participants at risk
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Placebo Phase 1 Cohort 2 Uncomplicated
n=1 participants at risk
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac Disorders
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
23.1%
3/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
100.0%
1/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
23.1%
3/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
General disorders
General Disorders
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Immune system disorders
Immune System Disorders
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Infections and Infestations
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
15.4%
2/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Nervous system disorders
Nervous System Disorders
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Thoracic and Mediastinal
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Vascular disorders
Vascular Disorders
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
Other adverse events
| Measure |
AP-SA02 Phase 2 Complicated
n=29 participants at risk
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 \^10
|
Placebo Phase 2 Complicated
n=13 participants at risk
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
AP-SA02 Phase 1 Cohort 1 Uncomplicated
n=3 participants at risk
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10\^9
|
AP-SA02 Phase 1 Cohort 2 Uncomplicated
n=3 participants at risk
Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10\^ 10
|
Placebo Phase 1 Cohort 1 Uncomplicated
n=1 participants at risk
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
Placebo Phase 1 Cohort 2 Uncomplicated
n=1 participants at risk
Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion
|
|---|---|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Abscess Soft Tissue
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Arthritis Bacterial
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Skin Infection
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Vascular disorders
Superficial Vein Thrombosis
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
2/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
15.4%
2/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Cardiac disorders
Cardiac Ventricular Thrombosis
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Cardiac disorders
Mitral Valve Incompetence
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Gastrointestinal disorders
Constipation
|
6.9%
2/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
General disorders
Catheter Site Erythema
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
General disorders
Catheter Site Pruritus
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
General disorders
Oedema
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
General disorders
Oedema Peripheral
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
General disorders
Peripheral Swelling
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
General disorders
Pyrexia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Arteriovenous Fistula Site Infection
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Arthritis Infective
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Endocarditis
|
6.9%
2/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Extradural abscess
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Janeway Lesion
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Oral Candidiasis
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Osler's Nodes
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Injury, poisoning and procedural complications
Penis Injury
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Klebsiella Test Positive
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Alanine Aminotransferase Increased
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
15.4%
2/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Cardiac Murmur
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
15.4%
2/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Nervous system disorders
Neuralgia
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Psychiatric disorders
Delirium
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Psychiatric disorders
Hallucination
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Congestion
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Bullous
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
1/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Skin and subcutaneous tissue disorders
Rash Vesicular
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
100.0%
1/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
7.7%
1/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
100.0%
1/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/29 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/13 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
33.3%
1/3 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
0.00%
0/1 • Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place