Trial Outcomes & Findings for A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study (NCT NCT05211947)
NCT ID: NCT05211947
Last Updated: 2026-04-08
Results Overview
Number of participants with treatment emergent adverse events.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1356 participants
Primary outcome timeframe
From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Results posted on
2026-04-08
Participant Flow
Multi-center, multi-national, open label, single arm extension trial in patients with cognitive impairment due to schizophrenia who had completed 26 weeks of treatment with 10 milligrams (mg) iclepertin or matching placebo, taken once daily in one of the three Phase III (CONNEX) parent trials (trial 1346-0011, 1346-0012 or 1346-0013).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Participant milestones
| Measure |
Iclepertin 10 mg
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
|
|---|---|
|
Overall Study
STARTED
|
1356
|
|
Overall Study
COMPLETED
|
632
|
|
Overall Study
NOT COMPLETED
|
724
|
Reasons for withdrawal
| Measure |
Iclepertin 10 mg
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
|
|---|---|
|
Overall Study
Study terminated by sponsor
|
557
|
|
Overall Study
Adverse Event
|
42
|
|
Overall Study
Perceived lack of efficacy
|
15
|
|
Overall Study
Burden of study procedures
|
12
|
|
Overall Study
Change of residence
|
10
|
|
Overall Study
Protocol deviation
|
3
|
|
Overall Study
No reason available
|
9
|
|
Overall Study
Other reason than listed
|
74
|
|
Overall Study
Missing reason
|
2
|
Baseline Characteristics
A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study
Baseline characteristics by cohort
| Measure |
Iclepertin 10 mg
n=1356 Participants
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
|
|---|---|
|
Age, Continuous
|
35.5 Years
STANDARD_DEVIATION 8.8 • n=527 Participants
|
|
Sex: Female, Male
Female
|
477 Participants
n=527 Participants
|
|
Sex: Female, Male
Male
|
879 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
425 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
912 Participants
n=527 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=527 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
103 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Asian
|
418 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Black or African American
|
112 Participants
n=527 Participants
|
|
Race (NIH/OMB)
White
|
682 Participants
n=527 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=527 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=527 Participants
|
PRIMARY outcome
Timeframe: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.Population: Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
Number of participants with treatment emergent adverse events.
Outcome measures
| Measure |
Iclepertin 10 mg
n=1356 Participants
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
|
|---|---|
|
Occurence of Treatment Emergent Adverse Events (TEAEs)
|
838 Participants
|
SECONDARY outcome
Timeframe: At baseline and at EOT. Up to a maximum of 60.1 weeks.Population: Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication. Patients without values at EOT were excluded from the analysis.
The change from baseline in the Clinical Global Impressions - Severity score (CGI-S) to end of treatment (EOT), calculated as \[CGI-S EOT\] - \[CGI-S baseline\] is reported. The CGI-S is composed of 1 question rated on a 4-point scale describing the severity of a patient's impairment, where 1 = none, 2 = mild, 3 = moderate, and 4 = severe.
Outcome measures
| Measure |
Iclepertin 10 mg
n=781 Participants
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
|
|---|---|
|
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) to End of Treatment (EOT)
|
-0.13 Units on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: At baseline and at EOT. Up to a maximum of 60.1 weeks.Population: Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication. Patients without a Hb value on-treatment were excluded from the analysis.
Change in haemoglobin (Hb) from baseline to end of treatment (EOT), calculated as \[last Hb on treatment\] - \[Hb baseline\], is reported.
Outcome measures
| Measure |
Iclepertin 10 mg
n=1337 Participants
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
|
|---|---|
|
Change From Baseline in Haemaglobin (Hb) to End of Treatment (EOT)
|
0.2 grams/liter
Standard Deviation 8.9
|
Adverse Events
Iclepertin 10 mg
Serious events: 82 serious events
Other events: 261 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Iclepertin 10 mg
n=1356 participants at risk
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Eye disorders
Glaucoma
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Gastrointestinal disorders
Anal fissure
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Gastrointestinal disorders
Anal fistula
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Appendicitis
|
0.15%
2/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Dengue fever
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Diverticulitis
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Enteritis infectious
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Influenza
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Pneumonia
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Sepsis
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Infections and infestations
Septic shock
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal papilloma
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary mediastinal large B-cell lymphoma
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Nervous system disorders
Epilepsy
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Nervous system disorders
Seizure
|
0.15%
2/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Anxiety
|
0.15%
2/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Completed suicide
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Depression
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Homicidal ideation
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Impulsive behaviour
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Schizophrenia
|
1.4%
19/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Self-destructive behaviour
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.44%
6/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Suicidal ideation
|
1.1%
15/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.22%
3/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Social circumstances
Family stress
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Vascular disorders
Thrombophlebitis
|
0.07%
1/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
Other adverse events
| Measure |
Iclepertin 10 mg
n=1356 participants at risk
Participants who received either placebo or iclepertin in the parent trials 1346-0011, 1346-0012, or 1346-0013 took a 10-milligram (mg) tablet of iclepertin once daily.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.5%
129/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Nervous system disorders
Headache
|
6.6%
89/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
|
Psychiatric disorders
Schizophrenia
|
5.5%
75/1356 • All-cause mortality: From first drug administration until individual end of trial. Up to a maximum of 64.1 weeks. Adverse event reporting: From first until last drug administration plus residual effect period. Up to a maximum of 61.9 weeks.
Treated set: all patients who signed informed consent and were treated with at least one dose of the trial medication.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER