Trial Outcomes & Findings for Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% (NCT NCT05659563)
NCT ID: NCT05659563
Last Updated: 2026-03-19
Results Overview
To assess changes in tumor cell proliferation as measured by Ki67 expression between baseline and D15 (+1 day) post-treatment tumor biopsy samples by central assessment in patients with centrally confirmed Ki67 ≥10% (Arm A: giredestrant vs Arm B: tamoxifen)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Baseline up to 15 days
Results posted on
2026-03-19
Participant Flow
Between July 2023 and December 2024 a total of 92 women ≥18 years of age with well-defined premenopausal status and previously untreated histologically confirmed ER\[+\]/HER2\[-\] primary invasive adenocarcinoma of the breast with locally analyzed and centrally confirmed Ki67≥10%, and tumor size ≥1.0 cm in longest diameter by ultrasound were enrolled at 20 sites. Due there is two arms, patients received Giredestrant or Tamoxifen until treatment completion or discontinuation from study
Premenopausal women ≥ 18 years of age with previously untreated disease. Histologically local confirmation of ER\[+\]/HER2\[-\] invasive breast carcinoma. Locally analyzed and centrally confirmed Ki67 ≥ 10%. Tumor size ≥ 1.0 cm (ultrasound). Absence of distant metastasis. ECOG PS 0-1. Willingness to provide a primary tumor tissue sample during the screening process and post-treatment tumor tissue sample. Adequate organ function.
Participant milestones
| Measure |
Arm A
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
|
Arm B
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
42
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Arm A
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
|
Arm B
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%
Baseline characteristics by cohort
| Measure |
Arm A
n=46 Participants
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
|
Arm B
n=46 Participants
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=110 Participants
|
46 Participants
n=114 Participants
|
92 Participants
n=224 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Age, Continuous
|
46.4 Years
n=110 Participants
|
45.9 Years
n=114 Participants
|
46.1 Years
n=224 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=110 Participants
|
46 Participants
n=114 Participants
|
92 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Caucassian
|
43 Participants
n=110 Participants
|
42 Participants
n=114 Participants
|
85 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Assian
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Latin
|
1 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
5 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
ECOG Performance status
0
|
45 Participants
n=110 Participants
|
42 Participants
n=114 Participants
|
87 Participants
n=224 Participants
|
|
ECOG Performance status
1
|
1 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
5 Participants
n=224 Participants
|
|
Primary Tumor (T)
T1b
|
3 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Primary Tumor (T)
T1c
|
21 Participants
n=110 Participants
|
20 Participants
n=114 Participants
|
41 Participants
n=224 Participants
|
|
Primary Tumor (T)
T2
|
20 Participants
n=110 Participants
|
25 Participants
n=114 Participants
|
45 Participants
n=224 Participants
|
|
Primary Tumor (T)
T3
|
2 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
3 Participants
n=224 Participants
|
|
Regional lymph nodes (N)
N0
|
43 Participants
n=110 Participants
|
42 Participants
n=114 Participants
|
85 Participants
n=224 Participants
|
|
Regional lymph nodes (N)
N1
|
3 Participants
n=110 Participants
|
4 Participants
n=114 Participants
|
7 Participants
n=224 Participants
|
|
Breast cancer staging
IA
|
23 Participants
n=110 Participants
|
20 Participants
n=114 Participants
|
43 Participants
n=224 Participants
|
|
Breast cancer staging
IB
|
1 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=224 Participants
|
|
Breast cancer staging
IIA
|
18 Participants
n=110 Participants
|
21 Participants
n=114 Participants
|
39 Participants
n=224 Participants
|
|
Breast cancer staging
IIB
|
4 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
9 Participants
n=224 Participants
|
|
Estrogen receptor status
|
46 Participants
n=110 Participants
|
46 Participants
n=114 Participants
|
92 Participants
n=224 Participants
|
|
Progesterone receptor status
Negative
|
5 Participants
n=110 Participants
|
1 Participants
n=114 Participants
|
6 Participants
n=224 Participants
|
|
Progesterone receptor status
Positive
|
41 Participants
n=110 Participants
|
45 Participants
n=114 Participants
|
86 Participants
n=224 Participants
|
|
HER2 IHC Score
0
|
21 Participants
n=110 Participants
|
19 Participants
n=114 Participants
|
40 Participants
n=224 Participants
|
|
HER2 IHC Score
1+
|
17 Participants
n=110 Participants
|
22 Participants
n=114 Participants
|
39 Participants
n=224 Participants
|
|
HER2 IHC Score
2+
|
8 Participants
n=110 Participants
|
5 Participants
n=114 Participants
|
13 Participants
n=224 Participants
|
|
Ki67 score
|
19.0 %
n=110 Participants
|
15.0 %
n=114 Participants
|
15.0 %
n=224 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 15 daysPopulation: Primary analysis is performed in modified Intentention-to-Treat analysis population
To assess changes in tumor cell proliferation as measured by Ki67 expression between baseline and D15 (+1 day) post-treatment tumor biopsy samples by central assessment in patients with centrally confirmed Ki67 ≥10% (Arm A: giredestrant vs Arm B: tamoxifen)
Outcome measures
| Measure |
Arm A
n=40 Participants
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
|
Arm B
n=44 Participants
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
|
|---|---|---|
|
Change in Proliferative Index (Ki67 Expression)
|
-14.5 Difference from baseline (%)
Interval -17.5 to -13.0
|
-10.0 Difference from baseline (%)
Interval -13.0 to -7.0
|
SECONDARY outcome
Timeframe: Baseline up to 15 daysPopulation: Seconday analysis is performed in the modified Intention-to-Treat analysis population
To measure complete cell cycle arrest in all arms, defined as the percentage of participants with centrally assessed Ki67 scores ≤2.7% stained nuclei upon treatment
Outcome measures
| Measure |
Arm A
n=40 Participants
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
|
Arm B
n=44 Participants
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
|
|---|---|---|
|
Complete Cell Cycle Arrest (CCCA)
|
17.5 % patients with CCCA
Interval 7.3 to 32.8
|
4.5 % patients with CCCA
Interval 0.6 to 15.5
|
SECONDARY outcome
Timeframe: Baseline up to 15 daysPopulation: Breast cancer intrinsic molecular subtypes were determined using the PAM50 gene expression assay. Tumors are categorized as Luminal A, Luminal B, HER2-enriched, Basal-like, or Normal-like. These subtypes reflect distinct tumor biology and are associated with different prognostic and therapeutic implications.
To analyze gene expression profiles in tumor tissue samples obtained at baseline and after treatment using the HTG EdgeSeq Oncology Biomarker Panel
Outcome measures
| Measure |
Arm A
n=40 Participants
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
|
Arm B
n=44 Participants
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
|
|---|---|---|
|
Changes in Molecular Profiles of Tumor Tissue Samples
End of treatment · Normal
|
11 Participants
|
4 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
End of treatment · Not evaluated
|
4 Participants
|
6 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
End of treatment · Basal
|
2 Participants
|
3 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
End of treatment · HER2
|
6 Participants
|
7 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
Baseline · Luminal A
|
9 Participants
|
5 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
Baseline · Luminal B
|
12 Participants
|
14 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
Baseline · Basal
|
6 Participants
|
8 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
Baseline · HER2
|
3 Participants
|
5 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
Baseline · Normal
|
4 Participants
|
4 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
Baseline · Not evaluated
|
6 Participants
|
8 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
End of treatment · Luminal A
|
14 Participants
|
18 Participants
|
|
Changes in Molecular Profiles of Tumor Tissue Samples
End of treatment · Luminal B
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 15 daysPopulation: Secondary analysis are performed on modified Intention-to-Treat population analysis
To analyze the expression of estrogen receptor and progesterone receptor in tumor tissue samples obtained at baseline and post-therapy
Outcome measures
| Measure |
Arm A
n=40 Participants
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
|
Arm B
n=44 Participants
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
|
|---|---|---|
|
Changes in Expression Levels of Estrogen Receptor and Progesterone Receptor in Tumor Tissue Samples
Estrogen Receptor
|
-39.9 Percentage
Interval -54.0 to -34.0
|
0.0 Percentage
Interval -7.0 to 2.0
|
|
Changes in Expression Levels of Estrogen Receptor and Progesterone Receptor in Tumor Tissue Samples
Progesterone Receptor
|
0.0 Percentage
Interval -21.0 to 0.0
|
-21.5 Percentage
Interval -43.5 to -21.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 15 daysTo compare the expression of blood biomarkers in samples obtained at baseline and post-therapy using a plasma endocrine panel
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 15 daysTo evaluate incidence and severity of adverse events, with severity determined in accordance to NCI-CTCAE v.5.0
Outcome measures
Outcome data not reported
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm B
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A
n=42 participants at risk
Giredestrant (GDC-9545): 30mg, orally (PO), daily (QD) during 15 days
|
Arm B
n=44 participants at risk
Tamoxifen: 20mg, orally (PO), daily (QD) during 15 days
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
2.4%
1/42 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
General disorders and administration site conditions
Fatigue
|
7.1%
3/42 • Number of events 3 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
9.1%
4/44 • Number of events 4 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
2.4%
1/42 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/42 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
2.3%
1/44 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
4/42 • Number of events 4 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
6.8%
3/44 • Number of events 3 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Nervous system disorders
Headache
|
7.1%
3/42 • Number of events 4 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
4.5%
2/44 • Number of events 4 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/42 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
2.3%
1/44 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Investigations
Oestradiol increased
|
4.8%
2/42 • Number of events 2 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Skin and subcutaneous tissue disorders
Trichorrhexis
|
0.00%
0/42 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
2.3%
1/44 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
2.4%
1/42 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Vascular disorders
Hot flush
|
9.5%
4/42 • Number of events 4 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
4.5%
2/44 • Number of events 3 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/42 • Number of events 2 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Nervous system disorders
Migraine
|
0.00%
0/42 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
2.3%
1/44 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.4%
1/42 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
2.3%
1/44 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/42 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
2.3%
1/44 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Cardiac disorders
Sinus bradycardia
|
2.4%
1/42 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
0.00%
0/44 • From treatment initiation until 28 days after the final dose of study treatment
Not related: The temporal association between the adverse event and the IMP makes a causal relationship unlikely, or the subject/patient's clinical state or the study procedure/conditions provide a sufficient explanation for the adverse event. Related: The temporal association between the adverse event and the IMP makes a causal relationship possible and the subject/patient's clinical state or the study procedure/conditions do not provide a sufficient explanation for the adverse event.
|
Additional Information
Chief Scientific Officer
Medica Scientia Innovation Research (MEDSIR)
Phone: +34 932 214 135
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place