Trial Outcomes & Findings for A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED) (NCT NCT05276063)
NCT ID: NCT05276063
Last Updated: 2026-08-26
Results Overview
Proptosis response is defined as a ≥ 2 mm reduction from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
90 participants
Primary outcome timeframe
24 weeks
Results posted on
2026-08-26
Participant Flow
Participants were recruited at investigative clinic sites and through central recruitment.
A total of 138 participants were screened (all participants who signed informed consent); 90 subjects were randomized after review of inclusion exclusion criteria and 48 were considered screen failures
Participant milestones
| Measure |
Placebo BID
Placebo Arm
|
75 mg BID
Active Arm: Linsitinib 75 mg BID
|
150 mg BID
Active Arm: Linsitinib 75 mg BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
22
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
Baseline characteristics by cohort
| Measure |
Placebo BID
n=30 Participants
Placebo Arm
|
75 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
150 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.9 Years
STANDARD_DEVIATION 12.70 • n=31 Participants
|
52.8 Years
STANDARD_DEVIATION 11.25 • n=49 Participants
|
50.1 Years
STANDARD_DEVIATION 14.29 • n=80 Participants
|
51.3 Years
STANDARD_DEVIATION 12.71 • n=29 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=31 Participants
|
19 Participants
n=49 Participants
|
21 Participants
n=80 Participants
|
57 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=31 Participants
|
11 Participants
n=49 Participants
|
9 Participants
n=80 Participants
|
33 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
7 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
8 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=31 Participants
|
25 Participants
n=49 Participants
|
23 Participants
n=80 Participants
|
74 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
1 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intent to Treat
Proptosis response is defined as a ≥ 2 mm reduction from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
Outcome measures
| Measure |
Placebo BID
n=30 Participants
Placebo Arm
|
75 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
150 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
|---|---|---|---|
|
Percentage of Subjects Who Are Proptosis Responders at Week 24
|
18.8 % of participants
|
38.9 % of participants
|
51.7 % of participants
|
SECONDARY outcome
Timeframe: 24 weeksOverall response is defined as a \>= 2-point reduction from baseline CAS and \>= 2 mm reduction in proptosis in the primary study eye at week 24 without deterioration (\>= 2-point increase) in CAS or deterioration (\>= 2 mm increase) of proptosis in the contralateral non-study eye. In the event of death, the latest CAS/proptosis observations will be carried forward. Missing values of CAS and proptosis measurement in the primary study eye and contralateral non-study eye at week 24 are multiple imputed by using all available prior CAS/proptosis measures, smoking status and treatment group.
Outcome measures
| Measure |
Placebo BID
n=30 Participants
Placebo Arm
|
75 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
150 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
|---|---|---|---|
|
Percentage of Subjects Who Are Overall Responders at Week 24
|
18.5 % of participants
|
37.3 % of participants
|
50.2 % of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Intent to Treat
A CAS value of 0 or 1 in primary study eye at week 24. In the event of death, the latest CAS observation will be carried forward. Missing values of CAS at week 24 are multiple imputed by using all available prior CAS measures, smoking status and treatment group
Outcome measures
| Measure |
Placebo BID
n=30 Participants
Placebo Arm
|
75 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
150 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
|---|---|---|---|
|
Percentage of Subjects With a CAS Value of 0 or 1 at Week 24
|
35.1 % of participants
|
47.7 % of participants
|
56.8 % of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Intent to Treat
Change from baseline to week 24 in Graves' Ophthalmology Quality of Life (GO-QoL) overall score or to last assessed value in case of death. Missing values of GO-QoL overall score up to week 24 are multiple imputed by using all available prior GO-QoL overall score measures, smoking status and treatment group. Overall scale was measured from 0 minimum to 100 maximum (0 is worse health state and 100 is best health state)
Outcome measures
| Measure |
Placebo BID
n=30 Participants
Placebo Arm
|
75 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
150 mg BID
n=30 Participants
Active Arm: Linsitinib 75 mg BID
|
|---|---|---|---|
|
Change From Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.
|
0.488 Score on Scale
Standard Error 2.699
|
6.387 Score on Scale
Standard Error 2.633
|
11.264 Score on Scale
Standard Error 3.057
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
75 mg BID
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
150 mg BID
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=31 participants at risk
Placebo Arm
|
75 mg BID
n=30 participants at risk
Active Arm: Linsitinib 75 mg BID
|
150 mg BID
n=29 participants at risk
Active Arm: Linsitinib150mg BID
|
|---|---|---|---|
|
Cardiac disorders
Pericardial Effusion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/30 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/29 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Investigations
Electrocardiogram T Wave Abnormal
|
0.00%
0/31 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/30 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.00%
0/31 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/30 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/30 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/29 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
Other adverse events
| Measure |
Placebo
n=31 participants at risk
Placebo Arm
|
75 mg BID
n=30 participants at risk
Active Arm: Linsitinib 75 mg BID
|
150 mg BID
n=29 participants at risk
Active Arm: Linsitinib150mg BID
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
2/31 • Number of events 2 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
13.3%
4/30 • Number of events 5 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
20.7%
6/29 • Number of events 6 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
10.0%
3/30 • Number of events 4 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
20.7%
6/29 • Number of events 9 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
General disorders
Fatigue
|
6.5%
2/31 • Number of events 2 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
20.0%
6/30 • Number of events 6 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
20.7%
6/29 • Number of events 8 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Nervous system disorders
Dizziness
|
9.7%
3/31 • Number of events 3 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/30 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.2%
1/31 • Number of events 1 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Investigations
ALT Increased
|
0.00%
0/31 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
10.0%
3/30 • Number of events 5 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
13.8%
4/29 • Number of events 5 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Investigations
AST Increased
|
0.00%
0/31 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
6.7%
2/30 • Number of events 3 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/31 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
13.8%
4/29 • Number of events 5 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/31 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/29 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
0.00%
0/30 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from time of signed informed consent through week 120 follow up.
Due to a randomization error, one participant assigned to the Linsitnib 150 mg BID group, however placebo was given. This participant was included in the efficacy analysis, but excluded from the safety analysis. This led to n =29 in the Linsitnib 150 mg BID and n = 31 in the placebo group for safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place