Trial Outcomes & Findings for Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1 (NCT NCT02171819)
NCT ID: NCT02171819
Last Updated: 2019-03-14
Results Overview
Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
75 participants
Primary outcome timeframe
60 min post injection
Results posted on
2019-03-14
Participant Flow
Participant milestones
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Placebo
phosphate buffered saline, given IM at Day 0 and Day 21.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
12
|
|
Overall Study
COMPLETED
|
31
|
32
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1
Baseline characteristics by cohort
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Placebo
n=12 Participants
phosphate buffered saline, given IM at Day 0 and Day 21.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
23.7 years
n=5 Participants
|
23.5 years
n=7 Participants
|
23.7 years
n=5 Participants
|
23.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Kinh
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
12 participants
n=5 Participants
|
75 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Khmer
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hoa
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Region of Enrollment
Vietnam
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
12 participants
n=5 Participants
|
75 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 min post injectionPopulation: Intent to treat population.
Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product.
Outcome measures
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Combined Vaccine
n=63 Participants
Results of low and high doses combined
|
Placebo
n=12 Participants
phosphate buffered saline, given IM at Day 0 and Day 21
|
|---|---|---|---|---|
|
Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after injectionPopulation: Participants who were randomized and received study injections
Data presented are after 1st and 2nd vaccination combined. Solicted reactogenicity are local and systemic events that are expected after injection and specifically asked of the participant. Only reported reactogenicity is presented. If not shown, then no participant reported that reaction in any study group. Local reactions are redness, swelling, pain, tenderness, and hardness. Systemic reactions are actual and subjective fever, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion. convulsions/seizures, fatigue/malaise, muscle aches (generalized), joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes. ear pain or discharge, rash, abdominal pain, diarrhea, vomiting, and jaundice.
Outcome measures
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Combined Vaccine
n=63 Participants
Results of low and high doses combined
|
Placebo
n=12 Participants
phosphate buffered saline, given IM at Day 0 and Day 21
|
|---|---|---|---|---|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Subjects with at least one solicted AE
|
26 Participants
|
26 Participants
|
52 Participants
|
4 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Subjects with at least one local solicted AE
|
25 Participants
|
24 Participants
|
49 Participants
|
3 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Subjects with at least one systemic solicited AE
|
13 Participants
|
14 Participants
|
27 Participants
|
4 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Local reactions--Pain
|
18 Participants
|
16 Participants
|
34 Participants
|
1 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Local reactions--Tenderness
|
21 Participants
|
23 Participants
|
44 Participants
|
3 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Diarrhea
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Abdominal pain
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Chills
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Cough
|
3 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Ear pain/discharge
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Fatigue/Malaise
|
3 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Fever
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Sore eyes
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Systemic reactogenicity--Sore throat
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Within 7 weeks of injectionPopulation: Intent to treat population. Please see more detail in the AE section of this posting. Table 14.2.1.2.1 Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term (After 1st and 2nd Vaccination Combined) Intention-to-Treat Population
Summary of number of participants with at least one unsolicited AE after 1st and 2nd vaccination combined. Please see the adverse event section of this report for full details.
Outcome measures
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Combined Vaccine
n=12 Participants
Results of low and high doses combined
|
Placebo
phosphate buffered saline, given IM at Day 0 and Day 21
|
|---|---|---|---|---|
|
Number of Participants With at Least One Unsolicited AE
|
12 Participants
|
12 Participants
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 3 weeks of any injectionPopulation: Table 14.2.2.3.1 Summary of Serious Unsolicited Adverse Events by System Organ Class and Preferred Term (After 1st and 2nd Vaccination Combined) Intention-to-Treat Population
Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.
Outcome measures
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Combined Vaccine
n=12 Participants
Results of low and high doses combined
|
Placebo
phosphate buffered saline, given IM at Day 0 and Day 21
|
|---|---|---|---|---|
|
All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 49Population: Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Outcome measures
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Combined Vaccine
n=63 Participants
Results of low and high doses combined
|
Placebo
n=12 Participants
phosphate buffered saline, given IM at Day 0 and Day 21
|
|---|---|---|---|---|
|
The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)
Post vaccination #1
|
7 Participants
|
9 Participants
|
16 Participants
|
0 Participants
|
|
The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)
Post vaccination #2
|
13 Participants
|
18 Participants
|
31 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 21 and 42Population: Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Outcome measures
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Combined Vaccine
n=63 Participants
Results of low and high doses combined
|
Placebo
n=12 Participants
phosphate buffered saline, given IM at Day 0 and Day 21
|
|---|---|---|---|---|
|
The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2
Baseline to post 1st vaccination
|
11 Participants
|
12 Participants
|
23 Participants
|
0 Participants
|
|
The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2
From post 1st- to post 2nd vaccination
|
9 Participants
|
11 Participants
|
20 Participants
|
0 Participants
|
|
The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2
Baseline to 2nd vaccination
|
21 Participants
|
23 Participants
|
44 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0, 21 and 42Population: Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Outcome measures
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Combined Vaccine
n=63 Participants
Results of low and high doses combined
|
Placebo
n=12 Participants
phosphate buffered saline, given IM at Day 0 and Day 21
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Day 0
|
5.00 Titers
Interval 5.0 to 5.0
|
5.00 Titers
Interval 5.0 to 5.0
|
5.00 Titers
Interval 5.0 to 5.0
|
5.00 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Post vaccination #1
|
12.8 Titers
Interval 7.95 to 20.58
|
11.9 Titers
Interval 8.17 to 17.31
|
12.3 Titers
Interval 9.19 to 16.53
|
5.00 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Post vaccination #2
|
24.5 Titers
Interval 15.51 to 38.58
|
27.1 Titers
Interval 19.98 to 36.71
|
25.8 Titers
Interval 19.77 to 33.57
|
5.00 Titers
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Days 0, 21, and 42Outcome measures
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 Participants
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 Participants
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Combined Vaccine
n=63 Participants
Results of low and high doses combined
|
Placebo
n=12 Participants
phosphate buffered saline, given IM at Day 0 and Day 21
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Post vaccination #2
|
21.9 Titers
Interval 13.91 to 34.38
|
23.3 Titers
Interval 16.54 to 32.76
|
22.6 Titers
Interval 17.16 to 29.7
|
5.00 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Day 0
|
5.00 Titers
Interval 5.0 to 5.0
|
5.00 Titers
Interval 5.0 to 5.0
|
5.00 Titers
Interval 5.0 to 5.0
|
5.00 Titers
Interval 5.0 to 5.0
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Post vaccination #1
|
9.4 Titers
Interval 5.99 to 14.6
|
9.4 Titers
Interval 6.52 to 13.46
|
9.4 Titers
Interval 7.09 to 12.36
|
5.00 Titers
Interval 5.0 to 5.0
|
Adverse Events
IVACFLU-A/H5N1, 7.5 mcg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
IVACFLU-A/H5N1, 15 mcg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IVACFLU-A/H5N1, 7.5 mcg
n=31 participants at risk
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
|
IVACFLU-A/H5N1, 15 mcg
n=32 participants at risk
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
|
Placebo
n=12 participants at risk
phosphate buffered saline, given IM at Day 0 and Day 21.
|
|---|---|---|---|
|
Immune system disorders
Immune system disorders
|
0.00%
0/31 • 90 days
|
0.00%
0/32 • 90 days
|
8.3%
1/12 • Number of events 1 • 90 days
|
|
Infections and infestations
Infections
|
0.00%
0/31 • 90 days
|
0.00%
0/32 • 90 days
|
8.3%
1/12 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/31 • 90 days
|
0.00%
0/32 • 90 days
|
8.3%
1/12 • Number of events 1 • 90 days
|
|
Investigations
Blood bilirubin increased
|
9.7%
3/31 • Number of events 3 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
Nervous system disorders
Headache
|
9.7%
3/31 • Number of events 3 • 90 days
|
6.2%
2/32 • Number of events 2 • 90 days
|
16.7%
2/12 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
5/31 • Number of events 5 • 90 days
|
6.2%
2/32 • Number of events 2 • 90 days
|
16.7%
2/12 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.5%
2/31 • Number of events 2 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharanyngeal pain
|
9.7%
3/31 • Number of events 3 • 90 days
|
6.2%
2/32 • Number of events 2 • 90 days
|
16.7%
2/12 • Number of events 2 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
16.1%
5/31 • Number of events 5 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
8.3%
1/12 • Number of events 1 • 90 days
|
|
Skin and subcutaneous tissue disorders
Pyrexia
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
8.3%
1/12 • Number of events 1 • 90 days
|
|
Ear and labyrinth disorders
Otorrhea
|
0.00%
0/31 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
Gastrointestinal disorders
Apthous stomatitis
|
0.00%
0/31 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
General disorders
Chills
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
General disorders
Feeling hot
|
0.00%
0/31 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
General disorders
Malaise
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/31 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/31 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
Investigations
Heart rate increased
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
Nervous system disorders
Dizziness postural
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
Psychiatric disorders
Depressed mood
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/31 • 90 days
|
3.1%
1/32 • Number of events 1 • 90 days
|
0.00%
0/12 • 90 days
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
0.00%
0/12 • 90 days
|
|
General disorders
Pyrexia
|
3.2%
1/31 • Number of events 1 • 90 days
|
0.00%
0/32 • 90 days
|
8.3%
1/12 • Number of events 1 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place