Trial Outcomes & Findings for Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers (NCT NCT02038842)
NCT ID: NCT02038842
Last Updated: 2026-04-14
Results Overview
Count of participants without any grade 3 or 4 adverse events (clinical or biological) related to MVA-vaccine immunisation, reported from Week 0 to Week 2 in arm 1
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Visit Week 2
Results posted on
2026-04-14
Participant Flow
Healthy volunteers will be recruited through the ARNS network of volunteers, through advertising via media and through a dedicated website, and given a telephone number to contact. From March 2014 to March 2015, 129 participants were screened in four sites in France.
Participant milestones
| Measure |
MVA HIV-B/LIPO-5
MVA HIV-B primes 0,5 milliliter (mL) Intramuscular at Week 0 and Week 8 LIPO-5 1mL Intramuscular boosts at Week 20 and Week 28
LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots;
MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;
|
LIPO-5/MVA HIV-B
LIPO-5 primes 1mL intramuscular at Week 0 and Week 8 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28
LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots;
MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;
|
GTU-MultiHIV B/LIPO-5
GTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and LIPO-5 1mL intramuscular boosts at Week 20 and Week 28
LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots;
GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
|
GTU-MultiHIV B/MVA HIV-B
GTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28
MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;
GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
21
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
5
|
4
|
Reasons for withdrawal
| Measure |
MVA HIV-B/LIPO-5
MVA HIV-B primes 0,5 milliliter (mL) Intramuscular at Week 0 and Week 8 LIPO-5 1mL Intramuscular boosts at Week 20 and Week 28
LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots;
MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;
|
LIPO-5/MVA HIV-B
LIPO-5 primes 1mL intramuscular at Week 0 and Week 8 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28
LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots;
MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;
|
GTU-MultiHIV B/LIPO-5
GTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and LIPO-5 1mL intramuscular boosts at Week 20 and Week 28
LIPO-5: LIPO-5: 1mL IntraMuscular, 2 shots;
GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
|
GTU-MultiHIV B/MVA HIV-B
GTU-MultiHIV B 0,5mL intramuscular via Biojector 2000 and 0,5mL intradermic primes at Week 0, Week 4 and Week 12 and MVA HIV-B 0,5mL intramuscular boosts at Week 20 and Week 28
MVA HIV-B (MVATG17401): MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;
GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots: GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
|
Overall Study
Participant decision
|
0
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
3
|
1
|
|
Overall Study
Other (professional impossibility, etc.)
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
MVA HIV-B/LIPO-5
n=23 Participants
MVA HIV-B primes 0,5mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
LIPO-5/MVA HIV-B
n=23 Participants
LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/LIPO-5
n=23 Participants
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/MVA HIV-B
n=23 Participants
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=193 Participants
|
23 Participants
n=193 Participants
|
23 Participants
n=386 Participants
|
23 Participants
n=112 Participants
|
92 Participants
n=103 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Age, Continuous
|
26 years
n=193 Participants
|
24 years
n=193 Participants
|
29 years
n=386 Participants
|
26 years
n=112 Participants
|
27 years
n=103 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=193 Participants
|
11 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
14 Participants
n=112 Participants
|
42 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
14 Participants
n=386 Participants
|
9 Participants
n=112 Participants
|
50 Participants
n=103 Participants
|
|
Region of Enrollment
France
|
23 participants
n=193 Participants
|
23 participants
n=193 Participants
|
23 participants
n=386 Participants
|
23 participants
n=112 Participants
|
92 participants
n=103 Participants
|
PRIMARY outcome
Timeframe: Visit Week 2Count of participants without any grade 3 or 4 adverse events (clinical or biological) related to MVA-vaccine immunisation, reported from Week 0 to Week 2 in arm 1
Outcome measures
| Measure |
MVA HIV-B/LIPO-5
n=23 Participants
MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
LIPO-5/MVA HIV-B
LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/LIPO-5
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/MVA HIV-B
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
|---|---|---|---|---|
|
Evaluation of the Safety of MVA HIV-B at Week 2 in Arm 1
|
22 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Visit Week 30Count of participants with a HIV-specific Interferon-gamma Enzyme Linked Immunosorbent SPOT (IFN-γ ELISPOT) response in each of the 4 arms, defined by a positive response to at least one of the stimulating HIV peptide pools (15-mer pools covering Env, Gag, Pol, and Nef) measured in stimulated Peripheral Blood Mononuclear Cell (PBMC) by a standard IFN-γ ELISPOT assay at Week 30, i.e. 2 weeks after the last vaccine immunisation.
Outcome measures
| Measure |
MVA HIV-B/LIPO-5
n=21 Participants
MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
LIPO-5/MVA HIV-B
n=21 Participants
LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/LIPO-5
n=19 Participants
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/MVA HIV-B
n=21 Participants
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
|---|---|---|---|---|
|
To Discard Vaccine Strategies With an Insufficient Level of Immunogenicity, Defined by HIV-specific IFN-γ-ELISPOT Responses, Among 4 HIV Prophylactic Prime-boost Combinations in Healthy Volunteers at Low Risk of HIV Infection
|
7 Participants
|
9 Participants
|
0 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Between week 0 and week 52Count of participants with at least one clinical/biological AE/SAE related to vaccine immunisation.
Outcome measures
| Measure |
MVA HIV-B/LIPO-5
n=23 Participants
MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
LIPO-5/MVA HIV-B
n=23 Participants
LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/LIPO-5
n=23 Participants
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/MVA HIV-B
n=23 Participants
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
|---|---|---|---|---|
|
To Assess the Tolerance of Each Prime-boost Combination
Clinical AE related to vaccine immunisation
|
22 Participants
|
21 Participants
|
21 Participants
|
23 Participants
|
|
To Assess the Tolerance of Each Prime-boost Combination
Clinical SAE related to vaccine immunisation
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
To Assess the Tolerance of Each Prime-boost Combination
Biological AE related to vaccine immunisation
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
To Assess the Tolerance of Each Prime-boost Combination
Biological SAE related to vaccine immunisation
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At W2, W10 and W22 for reporting groups : MVA HIV-B/LIPO-5 and LIPO-5/MVA HIV-B. And at W2, W6, W14 and W22 for reporting groups : GTU-MultiHIV B/LIPO-T and GTU-MultiHIV B/MVA HIV-B.Population: The number of participants differs due to the unavailability of some participants for some of the visits planned.
In all participants having received at least 1 dose of vaccine, the count of participants with HIV-specific ELISPOT response to at least one of stimulating HIV peptide pools.
Outcome measures
| Measure |
MVA HIV-B/LIPO-5
n=23 Participants
MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
LIPO-5/MVA HIV-B
n=23 Participants
LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/LIPO-5
n=23 Participants
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/MVA HIV-B
n=23 Participants
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
|---|---|---|---|---|
|
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response
Week 2
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response
Week 22
|
9 Participants
|
8 Participants
|
1 Participants
|
12 Participants
|
|
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response
Week 6
|
—
|
—
|
0 Participants
|
1 Participants
|
|
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response
Week 10
|
13 Participants
|
1 Participants
|
—
|
—
|
|
To Assess for Each Prime-boost Combination the Type of Vaccine-induced T Cell Response
Week 14
|
—
|
—
|
0 Participants
|
0 Participants
|
Adverse Events
MVA HIV-B/LIPO-5
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
LIPO-5/MVA HIV-B
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
GTU-MultiHIV B/LIPO-5
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
GTU-MultiHIV B/MVA HIV-B
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MVA HIV-B/LIPO-5
n=23 participants at risk
MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
LIPO-5/MVA HIV-B
n=23 participants at risk
LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/LIPO-5
n=23 participants at risk
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/MVA HIV-B
n=23 participants at risk
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Immune system disorders
Vitiligo
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Investigations
Blood urine present
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Investigations
Haemoglobin decreased
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Investigations
Lipase increased
|
4.3%
1/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Investigations
Protein urine present
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Investigations
Urine protein, quantitative
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Nervous system disorders
Migraine
|
4.3%
1/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Psychiatric disorders
Eating disorder
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
Other adverse events
| Measure |
MVA HIV-B/LIPO-5
n=23 participants at risk
MVA HIV-B primes 0,5 mL IntraMuscular at W0 and W8 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
LIPO-5/MVA HIV-B
n=23 participants at risk
LIPO-5 primes 1mL IntraMuscular at W0 and W8 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/LIPO-5
n=23 participants at risk
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 LIPO-5 1mL IntraMuscular boosts at W20 and W28
|
GTU-MultiHIV B/MVA HIV-B
n=23 participants at risk
GTU-MultiHIV B 0,5mL IntraMuscular via Biojector 2000 and 0,5mL IntraDermic primes at W0, W4 and W12 MVA HIV-B 0,5mL IntraMuscular boosts at W20 and W28
|
|---|---|---|---|---|
|
PSYCHIATRIC DISORDERS
IRRITABILITY
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
PSYCHIATRIC DISORDERS
SLEEP DISORDER
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
PSYCHIATRIC DISORDERS
STRESS
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RENAL AND URINARY DISORDERS
CALCULUS URINARY
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RENAL AND URINARY DISORDERS
DYSURIA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RENAL AND URINARY DISORDERS
PROTEINURIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
BREAST MASS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
DYSMENORRHOEA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
EPIDIDYMITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ASTHMA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
EPISTAXIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
OROPHARYNGEAL PAIN
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
RHINORRHOEA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
WHEEZING
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
ACNE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
DERMATOSIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
GENITAL RASH
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
PRURITUS ALLERGIC
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
RASH ERYTHEMATOUS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN DEPIGMENTATION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SURGICAL AND MEDICAL PROCEDURES
CYST REMOVAL
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SURGICAL AND MEDICAL PROCEDURES
PILONIDAL SINUS REPAIR
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SURGICAL AND MEDICAL PROCEDURES
VARICOSE VEIN OPERATION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
SURGICAL AND MEDICAL PROCEDURES
VISION CORRECTION OPERATION
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
VASCULAR DISORDERS
HOT FLUSH
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
VASCULAR DISORDERS
HYPERTENSION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
VASCULAR DISORDERS
HYPOTENSION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
VASCULAR DISORDERS
PRESYNCOPE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
VASCULAR DISORDERS
RAYNAUD'S PHENOMENON
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
VASCULAR DISORDERS
SYNCOPE
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANAEMIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
IRON DEFICIENCY ANAEMIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHADENITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
LYMPHADENOPATHY
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
CARDIAC DISORDERS
MITRAL VALVE PROLAPSE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
ENDOCRINE DISORDERS
HYPOTHYROIDISM
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
EYE DISORDERS
CONJUNCTIVITIS
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
EYE DISORDERS
OPHTHALMOPLEGIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
EYE DISORDERS
ULCERATIVE KERATITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL DISTENSION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
8.7%
2/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN LOWER
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN UPPER
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
AGEUSIA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
ANAL FISSURE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 5 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
DIARRHOEA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
DYSGEUSIA
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
HAEMORRHOIDS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
IRRITABLE BOWEL SYNDROME
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
LIP DRY
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
RECTAL HAEMORRHAGE
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
TOOTHACHE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
26.1%
6/23 • Number of events 6 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
26.1%
6/23 • Number of events 11 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
39.1%
9/23 • Number of events 14 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
34.8%
8/23 • Number of events 12 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FACIAL PAIN
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
30.4%
7/23 • Number of events 9 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
17.4%
4/23 • Number of events 5 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 6 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
39.1%
9/23 • Number of events 10 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INFLUENZA LIKE ILLNESS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
17.4%
4/23 • Number of events 5 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
17.4%
4/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE BRUISING
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE ERYTHEMA
|
30.4%
7/23 • Number of events 10 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
21.7%
5/23 • Number of events 5 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
30.4%
7/23 • Number of events 10 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
26.1%
6/23 • Number of events 14 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE GRANULOMA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE HAEMATOMA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
17.4%
4/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE HYPERSENSITIVITY
|
30.4%
7/23 • Number of events 7 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
26.1%
6/23 • Number of events 10 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
26.1%
6/23 • Number of events 10 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
39.1%
9/23 • Number of events 11 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE INDURATION
|
21.7%
5/23 • Number of events 7 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
30.4%
7/23 • Number of events 7 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
43.5%
10/23 • Number of events 15 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE IRRITATION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE JOINT MOVEMENT IMPAIRMENT
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE OEDEMA
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE PAIN
|
91.3%
21/23 • Number of events 54 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
82.6%
19/23 • Number of events 39 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
73.9%
17/23 • Number of events 36 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
87.0%
20/23 • Number of events 56 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE PARAESTHESIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE PRURITUS
|
8.7%
2/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
17.4%
4/23 • Number of events 5 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE RASH
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE SWELLING
|
13.0%
3/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
INJECTION SITE VESICLES
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
NJECTION SITE OEDEMA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PUNCTURE SITE PAIN
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
PYREXIA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
VESSEL PUNCTURE SITE HAEMATOMA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
HEPATOBILIARY DISORDERS
HAEMANGIOMA OF LIVER
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
HEPATOBILIARY DISORDERS
HYPERBILIRUBINAEMIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
IMMUNE SYSTEM DISORDERS
RHINITIS ALLERGIC
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
IMMUNE SYSTEM DISORDERS
RUBBER SENSITIVITY
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
BRONCHITIS
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
CONJUNCTIVITIS VIRAL
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
CYSTITIS
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
EAR INFECTION
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
FOLLICULITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
FURUNCLE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
GASTROENTERITIS
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
GASTROENTERITIS VIRAL
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
GINGIVITIS
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
HORDEOLUM
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
IMPETIGO
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
INFECTION PARASITIC
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
INFLUENZA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
MOLLUSCUM CONTAGIOSUM
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
NASOPHARYNGITIS
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
30.4%
7/23 • Number of events 8 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
26.1%
6/23 • Number of events 8 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
17.4%
4/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
ORAL HERPES
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
PHARYNGITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
RHINITIS
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
17.4%
4/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
RHINOTRACHEITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
SINUSITIS
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
SKIN BACTERIAL INFECTION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
TINEA INFECTION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
TINEA PEDIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
VAGINAL INFECTION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
VIRAL PHARYNGITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INFECTIONS AND INFESTATIONS
VIRAL RHINITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
CONTUSION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
LIGAMENT SPRAIN
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
TRAUMATIC HAEMATOMA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
BLOOD POTASSIUM DECREASED
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
BLOOD URINE PRESENT
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
HAEMOGLOBIN DECREASED
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
LIPASE INCREASED
|
4.3%
1/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
PROTEIN URINE PRESENT
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
INVESTIGATIONS
TRANSAMINASES INCREASED
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
METABOLISM AND NUTRITION DISORDERS
ABNORMAL LOSS OF WEIGHT
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
METABOLISM AND NUTRITION DISORDERS
DECREASED APPETITE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRALGIA
|
13.0%
3/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 5 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
COCCYDYNIA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
LIGAMENT SPRAIN
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCLE RIGIDITY
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCLE SPASMS
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL PAIN
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MYALGIA
|
21.7%
5/23 • Number of events 9 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
13.0%
3/23 • Number of events 4 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
17.4%
4/23 • Number of events 5 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
47.8%
11/23 • Number of events 16 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
SPINAL PAIN
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
TENDONITIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
TORTICOLLIS
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
8.7%
2/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
CERVICOBRACHIAL SYNDROME
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
FACIAL NEURALGIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
GRAND MAL CONVULSION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
34.8%
8/23 • Number of events 9 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
30.4%
7/23 • Number of events 12 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
26.1%
6/23 • Number of events 8 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
47.8%
11/23 • Number of events 25 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
HYPOAESTHESIA
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
MIGRAINE
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 2 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
MIGRAINE WITH AURA
|
4.3%
1/23 • Number of events 3 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
NERVE COMPRESSION
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
PARAESTHESIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
NERVOUS SYSTEM DISORDERS
VERTIGO
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
PSYCHIATRIC DISORDERS
ACUTE STRESS DISORDER
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
PSYCHIATRIC DISORDERS
DEPRESSION
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
0.00%
0/23 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
4.3%
1/23 • Number of events 1 • Each 92 participants were followed up for 52 weeks, unless they did not complete the study.
|
Additional Information
Pr. Jean-Daniel Lelièvre
Service d'immunologie clinique - Hôpital Henri Mondor
Phone: +33 1 49 81 24 55
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results until their public communication.
- Publication restrictions are in place
Restriction type: OTHER