Trial Outcomes & Findings for Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL (NCT NCT02557516)
NCT ID: NCT02557516
Last Updated: 2019-12-17
Results Overview
Number of dose-limiting toxicities, measured during the phase 1, dose escalation, part of the study.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-12-17
Participant Flow
It was anticipated that up to 24 patients (3 to 6 patients; 4 dose levels) would be enrolled in Phase 1 part of the study and up to 24 patients in the Phase 2 part with a total of up to 45 patients in the trial. A total of 22 patients were actually enrolled in the study: 13 patients in the Phase 1 part and 9 patients in the Phase 2 part.
The first part of the study had a 3+3 design. Four dose levels of monalizumab were planned: 1 mg/kg, 2 mg/kg, 4 mg/kg and 10 mg/kg. Dose-escalation decisions were made by a Safety Committee.The dose of monalizumab for all patients in phase 2 of the study (2 mg/kg) was also chosen by the Safety Committee based on phase 1 data.
Participant milestones
| Measure |
Phase 1 Level 1 - 1 mg/kg
During phase 1, patients received monalizumab, IV, at the dose of 1mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
Phase 1 Level 2 - 2 mg/kg
During phase 1, patients received monalizumab, IV, at the dose of 2 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
Phase 1 Level 3 - 4 mg/kg
During phase 1, patients received monalizumab, IV, at the dose of 4 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration IPH2201 was administered every 4 weeks.
|
Phase 2 RP2D - 2 mg/kg
During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1 part (2 mg/kg), combined with ibrutinib 420 mg orally, once daily, from the first administration and during 52 weeks.
The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
4
|
9
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
4
|
9
|
Reasons for withdrawal
| Measure |
Phase 1 Level 1 - 1 mg/kg
During phase 1, patients received monalizumab, IV, at the dose of 1mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
Phase 1 Level 2 - 2 mg/kg
During phase 1, patients received monalizumab, IV, at the dose of 2 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
Phase 1 Level 3 - 4 mg/kg
During phase 1, patients received monalizumab, IV, at the dose of 4 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration IPH2201 was administered every 4 weeks.
|
Phase 2 RP2D - 2 mg/kg
During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1 part (2 mg/kg), combined with ibrutinib 420 mg orally, once daily, from the first administration and during 52 weeks.
The first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
1
|
|
Overall Study
Disease progression
|
0
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
0
|
|
Overall Study
Sponsor decision
|
0
|
1
|
2
|
8
|
Baseline Characteristics
Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL
Baseline characteristics by cohort
| Measure |
Phase 1 Level 1 - 1 mg/kg
n=3 Participants
During phase 1, patients received monalizumab, IV, at the dose of 1 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
Phase 1 Level 2 - 2 mg/kg
n=6 Participants
During phase 1, patients received monalizumab, IV, at the dose of 2 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
Phase 1 Level 3 - 4 mg/kg
n=4 Participants
During phase 1, patients received monalizumab, IV, at the dose of 4 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
Phase 2 RP2D - 2 mg/kg
n=9 Participants
During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1 part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.
In both parts of the trial, the first 4 administrations of monalizumab occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 7.14 • n=7 Participants
|
69.5 years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 6.33 • n=4 Participants
|
67.1 years
STANDARD_DEVIATION 8.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
ECOG Performance Status
ECOG 0
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
ECOG Performance Status
ECOG 1
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
RAI Stage
Stage I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
RAI Stage
Stage II
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
RAI Stage
Stage III
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
RAI Stage
Stage IV
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Disease Status at Screening
Previously Untreated CLL
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Disease Status at Screening
Refractory CLL
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Disease Status at Screening
Relapse CLL
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: During phase 1 part of the study (dose escalation) the total number of patients evaluated for safety parameters is 13; 3 patients received at least one dose of monalizumab 1 mg/kg, 6 patients received 2 mg/kg , and 4 patients received 4 mg/kg.
Number of dose-limiting toxicities, measured during the phase 1, dose escalation, part of the study.
Outcome measures
| Measure |
Phase 1 Level 1 - 1 mg/kg
n=3 Participants
Phase 1 (dose escalation) evaluating dose level 1 (1 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 2 - 2 mg/kg
n=6 Participants
Phase 1 (dose escalation) evaluating dose level 2 of monalizumab (2 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 3 - 4 mg/kg
n=4 Participants
Phase 1 (dose escalation) evaluating dose level 3 (4 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 2 RP2D - 2 mg/kg
During phase 2a, patients received monalizumab, IV, at the dose recommended upon completion of phase 1b part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.
In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks
|
|---|---|---|---|---|
|
Number of Dose Limiting Toxicities
|
0 Dose Limiting Toxicy
|
1 Dose Limiting Toxicy
|
2 Dose Limiting Toxicy
|
—
|
PRIMARY outcome
Timeframe: CR assessed 52 weeks after the beginning of combination treatmentPopulation: Efficacy population: 21 patients who received at least one dose of monalizumab. According to the protocol, patients who discontinued treatment due to disease progression before the end of 8 weeks were replaced. Of note,1 patient (grade 3 hemolytic anemia due to disease progression at W4) was replaced and was then excluded from efficacy population.
The rate of complete response (CR) was evaluated using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) grading scale and confirmed by a bone marrow biopsy. Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL), Complete Response (CR) is defined as lymphocytes \<4x109/l, absence of lymphadenopathy, hepatomegaly and splenomegaly at CT scan, no constitutional symptoms, no cytopenia, normocellular bone marrow. Partial Response (PR) is a reduction \> 50% in lymphocytes, lymphadenopathy, spleen or liver, no cytopenia. PD if appearance of any new lesion, or increase in lymphocytes \> 50%, or occurrence of cytopenia attributable to CLL.
Outcome measures
| Measure |
Phase 1 Level 1 - 1 mg/kg
n=3 Participants
Phase 1 (dose escalation) evaluating dose level 1 (1 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 2 - 2 mg/kg
n=6 Participants
Phase 1 (dose escalation) evaluating dose level 2 of monalizumab (2 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 3 - 4 mg/kg
n=3 Participants
Phase 1 (dose escalation) evaluating dose level 3 (4 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 2 RP2D - 2 mg/kg
n=9 Participants
During phase 2a, patients received monalizumab, IV, at the dose recommended upon completion of phase 1b part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.
In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks
|
|---|---|---|---|---|
|
Rate of Complete Response (CR)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From beginning of study drug treatment to the end of study (up to 24 months)Population: Efficacy population: 21 patients who received at least one dose of monalizumab. According to the protocol, patients who discontinued treatment due to disease progression before the end of 8 weeks were replaced. Of note,1 patient (grade 3 hemolytic anemia due to disease progression at W4) was replaced and was then excluded from efficacy population.
Measure of best overall response at any time during the study. cCR: confirmed complete response/remission; uCR: unconfirmed complete response / remission; PR: partial response/remission; SD: stable disease; PD: progressive disease. Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL), Complete Response (CR) is defined as lymphocytes \<4x109/l, absence of lymphadenopathy, hepatomegaly and splenomegaly at CT scan, no constitutional symptoms, no cytopenia, normocellular bone marrow. Partial Response (PR) is a reduction \> 50% in lymphocytes, lymphadenopathy, spleen or liver, no cytopenia. PD if appearance of any new lesion, or increase in lymphocytes \> 50%, or occurrence of cytopenia attributable to CLL. In order to have a confirmed CR (cCR), the CR must be confirmed by a scan and a bone marrow assessment assessed at least 2 months after the first occurrence of CR. Otherwise it would be an unconfirmed CR (uCR).
Outcome measures
| Measure |
Phase 1 Level 1 - 1 mg/kg
n=3 Participants
Phase 1 (dose escalation) evaluating dose level 1 (1 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 2 - 2 mg/kg
n=6 Participants
Phase 1 (dose escalation) evaluating dose level 2 of monalizumab (2 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 3 - 4 mg/kg
n=3 Participants
Phase 1 (dose escalation) evaluating dose level 3 (4 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 2 RP2D - 2 mg/kg
n=9 Participants
During phase 2a, patients received monalizumab, IV, at the dose recommended upon completion of phase 1b part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.
In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks
|
|---|---|---|---|---|
|
Best Overall Response / Remission Rates
PD
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response / Remission Rates
cCR
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response / Remission Rates
uCR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response / Remission Rates
PR
|
2 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Best Overall Response / Remission Rates
SD
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 21 patients evaluated for efficacy. 1 patient treated at 4 mg/kg was withdrawn due to grade 3 hemolytic anemia attribuated to disease progression at W4 and considered as not evaluable for efficacy. Due to the small size of the trial no subgroup analyses have been conducted.
The duration of remission (DOR) is defined as the time from the date of first evaluation of the remission (cCR, uCR or PR) to the first documentation of progressive disease, relapsed disease or death. In case an assessment of progressive / relapsed disease or death does not exist, the DOR was censored at the time of the last disease assessment date. The DOR was calculated only for the patients with a remission that was assessed at 52 weeks.
Outcome measures
| Measure |
Phase 1 Level 1 - 1 mg/kg
n=21 Participants
Phase 1 (dose escalation) evaluating dose level 1 (1 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 2 - 2 mg/kg
Phase 1 (dose escalation) evaluating dose level 2 of monalizumab (2 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 3 - 4 mg/kg
Phase 1 (dose escalation) evaluating dose level 3 (4 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 2 RP2D - 2 mg/kg
During phase 2a, patients received monalizumab, IV, at the dose recommended upon completion of phase 1b part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.
In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks
|
|---|---|---|---|---|
|
Duration of Remission
|
NA Month
A median DOR could not be estimated at the time of data cut-off.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All 22 enrolled patients were included in the ITT / Safety population
The Progression Free Survival (PFS) is defined as the time from first dose administration until the occurrence of progressive disease, relapsed disease or death from any cause. Patients without an event at the time of the analyse were censored at his or her last disease assessment date. Patients with no post-Baseline assessment were censored at the day of the first dose administration.
Outcome measures
| Measure |
Phase 1 Level 1 - 1 mg/kg
n=22 Participants
Phase 1 (dose escalation) evaluating dose level 1 (1 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 2 - 2 mg/kg
Phase 1 (dose escalation) evaluating dose level 2 of monalizumab (2 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 3 - 4 mg/kg
Phase 1 (dose escalation) evaluating dose level 3 (4 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 2 RP2D - 2 mg/kg
During phase 2a, patients received monalizumab, IV, at the dose recommended upon completion of phase 1b part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.
In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks
|
|---|---|---|---|---|
|
Progression Free Survival
|
NA Month
A PFS median could not be estimated at the time of data cut-off.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 months.Population: 22 patients were included in the ITT / Safety population
The overall survival (OS) is defined as the time from first dose administration until death from any cause. Alive patients were censored at the most recent date they were known to be alive. Subjects with no assessment post-Baseline were censored at the day of the first dose administration.
Outcome measures
| Measure |
Phase 1 Level 1 - 1 mg/kg
n=22 Participants
Phase 1 (dose escalation) evaluating dose level 1 (1 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 2 - 2 mg/kg
Phase 1 (dose escalation) evaluating dose level 2 of monalizumab (2 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 1 Level 3 - 4 mg/kg
Phase 1 (dose escalation) evaluating dose level 3 (4 mg/kg) of monalizumab alone during 4 weeks then in combination with ibrutinib during 52 weeks.
|
Phase 2 RP2D - 2 mg/kg
During phase 2a, patients received monalizumab, IV, at the dose recommended upon completion of phase 1b part, combined with ibrutinib 420 mg orally, once daily, from the first cycle and during 52 weeks.
In both parts of the trial, the first 4 administrations of IPH2201 occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks
|
|---|---|---|---|---|
|
Overall Survival
|
NA Month
At the time of data cut-off, all 22 phase 1 and phase 2 patients were alive.
|
—
|
—
|
—
|
Adverse Events
1 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
2 mg/kg
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
4 mg/kg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 mg/kg
n=3 participants at risk
During phase 1b, patients received monalizumab, IV, at the dose of 1mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
|
2 mg/kg
n=15 participants at risk
During phase 1b and during phase 2a patients received monalizumab, IV, at the dose of 2 mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
|
4 mg/kg
n=4 participants at risk
During phase 1b, patients receivde monalizumab, IV, at the dose of 4 mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
|
|---|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Urosepsis
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Amylase increased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
Other adverse events
| Measure |
1 mg/kg
n=3 participants at risk
During phase 1b, patients received monalizumab, IV, at the dose of 1mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
|
2 mg/kg
n=15 participants at risk
During phase 1b and during phase 2a patients received monalizumab, IV, at the dose of 2 mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
|
4 mg/kg
n=4 participants at risk
During phase 1b, patients receivde monalizumab, IV, at the dose of 4 mg/kg, in combination with ibrutinib 420 mg, orally, once daily.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
53.3%
8/15 • Number of events 8 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
66.7%
2/3 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
33.3%
5/15 • Number of events 5 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
66.7%
2/3 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
66.7%
2/3 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
26.7%
4/15 • Number of events 5 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Eye disorders
Cataract
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Eye disorders
Eye discharge
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Eye disorders
Ocular hyperaemia
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 5 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
60.0%
9/15 • Number of events 15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
100.0%
4/4 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
33.3%
5/15 • Number of events 5 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Oral pain
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
26.7%
4/15 • Number of events 5 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
40.0%
6/15 • Number of events 9 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Chest pain
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Chills
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
26.7%
4/15 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Cyst
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Cyst rupture
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Facial pain
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
26.7%
4/15 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Feeling jittery
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Localised oedema
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Mass
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Oedema
|
33.3%
1/3 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Gastroenteritis viral
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Lip infection
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Oral infection
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
33.3%
5/15 • Number of events 6 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 5 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Urosepsis
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Contusion
|
100.0%
3/3 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
53.3%
8/15 • Number of events 13 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Head injury
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Amylase increased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Blood sodium decreased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Haemoglobin decreased
|
33.3%
1/3 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Lipase increased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Lymphocyte count increased
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Investigations
Weight increased
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
2/3 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
33.3%
5/15 • Number of events 5 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
53.3%
8/15 • Number of events 12 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
46.7%
7/15 • Number of events 8 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Cognitive disorder
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
33.3%
5/15 • Number of events 6 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
20.0%
3/15 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
26.7%
4/15 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
33.3%
1/3 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
26.7%
4/15 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
13.3%
2/15 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
33.3%
5/15 • Number of events 15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/15 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
25.0%
1/4 • Number of events 2 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
6.7%
1/15 • Number of events 1 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
0.00%
0/4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 4 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
46.7%
7/15 • Number of events 20 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
50.0%
2/4 • Number of events 3 • The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).
|
Additional Information
Dr. Agnes BOYER-CHAMMARD, Medical Director
Innate Pharma
Phone: +33430303030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place