Trial Outcomes & Findings for Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR) (NCT NCT01687387)
NCT ID: NCT01687387
Last Updated: 2019-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
152 participants
Primary outcome timeframe
from date of randomization until the date of first documented relapse, assessed up to 48 months
Results posted on
2019-02-08
Participant Flow
169 patients were screened and 152 patients were randomized and treated in France
Participant milestones
| Measure |
IPH2102 at 1 mg/kg
lirilumab (IPH2102/BMS986015) at 1 mg/kg
IPH2102 at 1 mg/kg: every 4 weeks
|
IPH2102 at 0.1 mg/kg
lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
IPH2102 at 0.1 mg/kg: every 3 months
Placebo (normal saline solution): every 4 weeks
|
Placebo (Normal Saline Solution)
Normal saline solution
Placebo (normal saline solution): every 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
51
|
|
Overall Study
COMPLETED
|
10
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
41
|
38
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IPH2102 at 1 mg/kg
n=51 Participants
lirilumab (IPH2102/BMS986015) at 1 mg/kg
IPH2102 at 1 mg/kg: every 4 weeks
|
IPH2102 at 0.1 mg/kg
n=50 Participants
lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
IPH2102 at 0.1 mg/kg: every 3 months
Placebo (normal saline solution): every 4 weeks
|
Placebo (Normal Saline Solution)
n=51 Participants
Normal saline solution
Placebo (normal saline solution): every 4 weeks
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=51 Participants
|
70 years
n=50 Participants
|
68 years
n=51 Participants
|
70 years
n=152 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=51 Participants
|
16 Participants
n=50 Participants
|
17 Participants
n=51 Participants
|
61 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=51 Participants
|
34 Participants
n=50 Participants
|
34 Participants
n=51 Participants
|
91 Participants
n=152 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
51 participants
n=51 Participants
|
50 participants
n=50 Participants
|
51 participants
n=51 Participants
|
152 participants
n=152 Participants
|
PRIMARY outcome
Timeframe: from date of randomization until the date of first documented relapse, assessed up to 48 monthsOutcome measures
| Measure |
IPH2102 at 1 mg/kg
n=51 Participants
lirilumab (IPH2102/BMS986015) at 1 mg/kg
IPH2102 at 1 mg/kg: every 4 weeks
|
IPH2102 at 0.1 mg/kg
n=50 Participants
lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
IPH2102 at 0.1 mg/kg: every 3 months
Placebo (normal saline solution): every 4 weeks
|
Placebo (Normal Saline Solution)
n=51 Participants
Normal saline solution
Placebo (normal saline solution): every 4 weeks
|
|---|---|---|---|
|
Leukemia-Free Survival
|
6.7 MONTHS
Interval 2.9 to 14.8
|
17.6 MONTHS
Interval 11.2 to 25.0
|
13.9 MONTHS
Interval 7.9 to 27.9
|
SECONDARY outcome
Timeframe: from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 monthsNumber of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs
Outcome measures
| Measure |
IPH2102 at 1 mg/kg
n=51 Participants
lirilumab (IPH2102/BMS986015) at 1 mg/kg
IPH2102 at 1 mg/kg: every 4 weeks
|
IPH2102 at 0.1 mg/kg
n=50 Participants
lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
IPH2102 at 0.1 mg/kg: every 3 months
Placebo (normal saline solution): every 4 weeks
|
Placebo (Normal Saline Solution)
n=51 Participants
Normal saline solution
Placebo (normal saline solution): every 4 weeks
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
43 Participants
|
49 Participants
|
47 Participants
|
Adverse Events
IPH2102 at 1 mg/kg
Serious events: 12 serious events
Other events: 38 other events
Deaths: 32 deaths
IPH2102 at 0.1 mg/kg
Serious events: 17 serious events
Other events: 48 other events
Deaths: 26 deaths
Placebo (Normal Saline Solution)
Serious events: 11 serious events
Other events: 43 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
IPH2102 at 1 mg/kg
n=51 participants at risk
lirilumab (IPH2102/BMS986015) at 1 mg/kg
IPH2102 at 1 mg/kg: every 4 weeks
|
IPH2102 at 0.1 mg/kg
n=50 participants at risk
lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
IPH2102 at 0.1 mg/kg: every 3 months
Placebo (normal saline solution): every 4 weeks
|
Placebo (Normal Saline Solution)
n=51 participants at risk
Normal saline solution
Placebo (normal saline solution): every 4 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Congenital, familial and genetic disorders
Hydrocele
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Endocrine disorders
Hyperthyroidism
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Eye disorders
Chorioretinal disorder
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Umbilical hernia
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Fatigue
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
General physical health deterioration
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Pyrexia
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Anal abscess
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Device related infection
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Peritonitis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Sepsis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Septic shock
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Staphylococcal sepsis
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Urosepsis
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Injury, poisoning and procedural complications
Head injury
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Injury, poisoning and procedural complications
Injury corneal
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Investigations
Biopsy spleen
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxofibrosarcoma
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Nervous system disorders
Sciatica
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Surgical and medical procedures
Respiratory therapy
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
Other adverse events
| Measure |
IPH2102 at 1 mg/kg
n=51 participants at risk
lirilumab (IPH2102/BMS986015) at 1 mg/kg
IPH2102 at 1 mg/kg: every 4 weeks
|
IPH2102 at 0.1 mg/kg
n=50 participants at risk
lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
IPH2102 at 0.1 mg/kg: every 3 months
Placebo (normal saline solution): every 4 weeks
|
Placebo (Normal Saline Solution)
n=51 participants at risk
Normal saline solution
Placebo (normal saline solution): every 4 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
10.0%
5/50 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.8%
4/51 • Number of events 9 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
8.0%
4/50 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
9.8%
5/51 • Number of events 11 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.6%
9/51 • Number of events 9 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
14.0%
7/50 • Number of events 11 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Eye disorders
Conjunctivitis
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Constipation
|
3.9%
2/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
10.0%
5/50 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
7/51 • Number of events 8 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
12.0%
6/50 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
7.8%
4/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
12.0%
6/50 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Asthenia
|
27.5%
14/51 • Number of events 20 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
28.0%
14/50 • Number of events 19 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
27.5%
14/51 • Number of events 22 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Chest pain
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
8.0%
4/50 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Chills
|
7.8%
4/51 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Fatigue
|
9.8%
5/51 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Influenza like illness
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
8.0%
4/50 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
9.8%
5/51 • Number of events 9 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Oedema peripheral
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
General disorders
Pyrexia
|
11.8%
6/51 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
9.8%
5/51 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Bronchitis
|
11.8%
6/51 • Number of events 9 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
34.0%
17/50 • Number of events 20 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
27.5%
14/51 • Number of events 15 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
8.0%
4/50 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
12.0%
6/50 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
11.8%
6/51 • Number of events 7 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Oral herpes
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Rhinitis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 8 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
9.8%
5/51 • Number of events 7 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Investigations
Lipase increased
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Investigations
Weight increased
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
10.0%
5/50 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
11.8%
6/51 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
12.0%
6/50 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
9.8%
5/51 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
12.0%
6/50 • Number of events 7 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
13.7%
7/51 • Number of events 8 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
8.0%
4/50 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
7.8%
4/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/50 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
9.8%
5/51 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
11.8%
6/51 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Nervous system disorders
Headache
|
15.7%
8/51 • Number of events 9 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
8.0%
4/50 • Number of events 9 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Nervous system disorders
Neuropathy peripheral
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
12.0%
6/50 • Number of events 9 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Nervous system disorders
Sciatica
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Psychiatric disorders
Anxiety
|
7.8%
4/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 5 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.8%
4/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/50 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
2.0%
1/51 • Number of events 1 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/51 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
4.0%
2/50 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
6.0%
3/50 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
5.9%
3/51 • Number of events 3 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.7%
8/51 • Number of events 9 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
20.0%
10/50 • Number of events 11 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
13.7%
7/51 • Number of events 12 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • Number of events 2 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
10.0%
5/50 • Number of events 6 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
3.9%
2/51 • Number of events 4 • AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place