Trial Outcomes & Findings for THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines (NCT NCT05370040)
NCT ID: NCT05370040
Last Updated: 2025-03-11
Results Overview
Incidence of medically-attended adverse events (MAAEs)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
through 1 week post final vaccine administration
Results posted on
2025-03-11
Participant Flow
Participant milestones
| Measure |
Phase 1 Cohort 1A
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase 1 Cohort 1A
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines
Baseline characteristics by cohort
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 7.53 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 7.10 • n=4 Participants
|
32.7 years
STANDARD_DEVIATION 11.44 • n=21 Participants
|
29.3 years
STANDARD_DEVIATION 7.48 • n=8 Participants
|
32.7 years
STANDARD_DEVIATION 9.51 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Healthy adults vaccinated with an EUA or approved vaccine against COVID-19 ≥3 months prior to enroll
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: through 1 week post final vaccine administrationIncidence of medically-attended adverse events (MAAEs)
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of MAAEs Through 1 Week
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: through 30 days post final vaccine administrationIncidence of MAAEs
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of MAAEs Through 30 Days
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: through 6 months post final vaccine administrationIncidence of MAAEs
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of MAAEs Through 6 Months
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: through 1 week after each vaccine doseIncidence and severity of solicited local reactogenicity AEs
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of Solicited Local Reactogenicity AEs
|
9 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: through 1 week after each vaccine doseIncidence and severity of solicited systemic reactogenicity AEs
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of Solicited Systemic Reactogenicity AEs
|
9 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: through 1 week post final vaccine administrationIncidence and severity of unsolicited AEs
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of Unsolicited AEs Through 1 Week
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: through 30 days post final vaccine administrationIncidence and severity of unsolicited AEs
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of Unsolicited AEs Through 30 Days
|
5 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: through 1 week post final vaccine administrationIncidence of serious adverse events (SAEs)
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of SAEs Through 1 Week
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: through 30 days post final vaccine administrationIncidence of SAEs
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of SAEs Through 30 Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: through 6 months post final vaccine administrationIncidence of SAEs
Outcome measures
| Measure |
Phase 1 Cohort 1A
n=10 Participants
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 Participants
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 Participants
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 Participants
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 Participants
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 Participants
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
|---|---|---|---|---|---|---|
|
Phase 1 Safety - Incidence of SAEs Through 6 Months
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Phase 1 Cohort 1A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Cohort 1B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Cohort 1C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Cohort 2A
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Cohort 2B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 1 Cohort 2C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1: Cohort 1A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 1: Cohort 1B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 1: Cohort 1C
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 1: Cohort 2A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 1: Cohort 2B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 1: Cohort 2C
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2: Cohort 1A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2: Cohort 1B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2: Cohort 1C
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2: Cohort 2A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: Cohort 2B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2: Cohort 2C
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 3: Cohort 1A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: Cohort 1B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 3: Cohort 1C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: Cohort 2A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 3: Cohort 2B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: Cohort 2C
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 4: Cohort 1A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4: Cohort 1B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4: Cohort 1C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 4: Cohort 2A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 4: Cohort 2B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 4: Cohort 2C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Cohort 1A
n=10 participants at risk
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 participants at risk
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 participants at risk
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 participants at risk
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 participants at risk
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 participants at risk
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Group 1: Cohort 1A
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 1B
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 1C
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 2A
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 2B
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 2C
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 1A
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 1B
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 1C
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 2A
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 2B
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 2C
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 3: Cohort 1A
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 1B
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 1C
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 2A
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 2B
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 2C
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 4: Cohort 1A
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 1B
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 1C
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 2A
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 2B
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 2C
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
Other adverse events
| Measure |
Phase 1 Cohort 1A
n=10 participants at risk
AAHI-SC2 on Day 1 at dosage 25 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1B
n=10 participants at risk
AAHI-SC2 on Day 1 at dosage 50 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 1C
n=10 participants at risk
AAHI-SC2 on Day 1 at dosage 70 μg IM
AAHI-SC2 Vaccine: AAHI -SC2 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2A
n=10 participants at risk
AAHI-SC3 on Day 1 at dosage 25 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2B
n=10 participants at risk
AAHI-SC3 on Day 1 at dosage 50 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Phase 1 Cohort 2C
n=10 participants at risk
AAHI-SC3 on Day 1 at dosage 85 μg IM
AAHI-SC3 Vaccine: AAHI-SC3 self-amplifying RNA (saRNA) against SARS-CoV-2 Spike and nucleocapsid protein delivered by nanostructured lipid carrier (NLC) Vaccine
|
Group 1: Cohort 1A
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 1B
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 1C
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 2A
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 2B
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 1: Cohort 2C
n=10 participants at risk
Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 1A
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 1B
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 1C
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 2A
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 2B
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 2: Cohort 2C
n=10 participants at risk
Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration
|
Group 3: Cohort 1A
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 1B
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 1C
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 2A
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 2B
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 3: Cohort 2C
n=10 participants at risk
Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration
|
Group 4: Cohort 1A
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 1B
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 1C
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 2A
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 2B
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
Group 4: Cohort 2C
n=10 participants at risk
Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
80.0%
8/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
90.0%
9/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
80.0%
8/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
70.0%
7/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
90.0%
9/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
90.0%
9/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Injection site pruritus
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
60.0%
6/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Injection site swelling
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Injection site bruising
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Injection site erythema
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Chills
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
70.0%
7/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
70.0%
7/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
60.0%
6/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Fatigue
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
General disorders
Asthenia
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
70.0%
7/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
90.0%
9/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
90.0%
9/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
60.0%
6/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
80.0%
8/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
70.0%
7/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
60.0%
6/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
80.0%
8/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
80.0%
8/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
80.0%
8/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
80.0%
8/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
70.0%
7/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
100.0%
10/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
100.0%
10/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
60.0%
6/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
80.0%
8/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
70.0%
7/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
60.0%
6/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
60.0%
6/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
50.0%
5/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
40.0%
4/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
30.0%
3/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
20.0%
2/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
10.0%
1/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
0.00%
0/10 • For 30 days after the last dose, at each study visit, the Investigator was to inquire about the occurrence of AE/SAEs since the last visit or follow-up. From 30 days after the last dose to 6 months after the last dose, at each study visit, the Investigator was to inquire about the occurrence of SAEs since the last visit or follow-up. Events were to be followed for outcome information until resolution or stabilization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place