Trial Outcomes & Findings for Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations (NCT NCT01953926)
NCT ID: NCT01953926
Last Updated: 2024-03-12
Results Overview
Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
582 participants
Primary outcome timeframe
From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 months
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Neratinib
Neratinib Monotherapy (Neratinib 240 mg PO daily)
|
Neratinib + Fulvestrant
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
|
Neratinib + Paclitaxel
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
|
Neratinib + Trastuzumab
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Neratinib + Fulvestrant + Trastuzumab
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Fulvestrant
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
|
Fulvestrant + Trastuzumab
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
318
|
45
|
23
|
92
|
90
|
7
|
7
|
|
Overall Study
Treated
|
317
|
45
|
22
|
92
|
90
|
7
|
7
|
|
Overall Study
COMPLETED
|
231
|
31
|
14
|
70
|
32
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
87
|
14
|
9
|
22
|
58
|
5
|
7
|
Reasons for withdrawal
| Measure |
Neratinib
Neratinib Monotherapy (Neratinib 240 mg PO daily)
|
Neratinib + Fulvestrant
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
|
Neratinib + Paclitaxel
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
|
Neratinib + Trastuzumab
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Neratinib + Fulvestrant + Trastuzumab
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Fulvestrant
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
|
Fulvestrant + Trastuzumab
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
23
|
3
|
3
|
5
|
6
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
18
|
3
|
0
|
5
|
3
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other, Disease progression
|
2
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Discontinuation of study by sponsor
|
41
|
7
|
5
|
12
|
46
|
5
|
6
|
|
Overall Study
Not Treated
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Baseline characteristics by cohort
| Measure |
Neratinib
n=317 Participants
Neratinib Monotherapy (Neratinib 240 mg PO daily)
|
Neratinib + Fulvestrant
n=45 Participants
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
|
Neratinib + Paclitaxel
n=22 Participants
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
|
Neratinib + Trastuzumab
n=92 Participants
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Neratinib + Fulvestrant + Trastuzumab
n=90 Participants
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Fulvestrant
n=7 Participants
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
|
Fulvestrant + Trastuzumab
n=7 Participants
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Total
n=580 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
201 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
358 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
116 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
222 Participants
n=24 Participants
|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
69.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
59.2 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
58.3 years
STANDARD_DEVIATION 11.2 • n=8 Participants
|
62.0 years
STANDARD_DEVIATION 12.4 • n=8 Participants
|
60.0 years
STANDARD_DEVIATION 12.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
399 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
181 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
255 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
473 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
16 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
|
Tumor type
Breast cancer HR+ or HR-
|
36 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
|
Tumor type
Breast cancer HR+
|
0 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
76 Participants
n=24 Participants
|
|
Tumor type
Breast cancer HR+, prior CDK46 inhibitors
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
73 Participants
n=24 Participants
|
|
Tumor type
Breast cancer HR-
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
|
Tumor type
Lung Her2 mutant cancer
|
26 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
78 Participants
n=24 Participants
|
|
Tumor type
Lung EGFR mutant exon 18 cancer
|
31 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
|
Tumor type
Biliary tract cancer
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Tumor type
Cervical cancer
|
22 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
|
Tumor type
Bladder/Urinary Tract cancer
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Tumor type
Brain EGFR mutant cancer
|
38 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
|
Tumor type
Colorectal cancer
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
31 Participants
n=24 Participants
|
|
Tumor type
Salivary gland cancer
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Tumor type
Endometrial cancer
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Tumor type
Fibrolamellar carcinoma (FLC)
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
|
Tumor type
Gastroesophageal cancer
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Tumor type
Ovarian cancer
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
|
Tumor type
HER2 NOS cancer
|
42 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
42 Participants
n=24 Participants
|
|
Tumor type
HER3 NOS cancer
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
|
Tumor type
HER4 NOS cancer
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 monthsPopulation: Cohort of cancer type and treatment
Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=59 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=7 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=7 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Objective Response Rate (ORR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
|
40.7 percentage of participants
|
0 percentage of participants
|
14.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
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|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 monthsPopulation: Cohort of cancer type and treatment
Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (cervical cancer cohort). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=22 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Objective Response Rate (ORR) by Investigator Review (Cervical Cancer Cohort)
|
18.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first treatment date to first Complete or Partial Response, whichever came earlier, assessed up to 8 or 9 weeksPopulation: Cohort of cancer type and treatment
Percentage of participants who achieve CR or PR per Response Evaluation Criteria in Sold Tumors Criteria (RECIST) v1.1, or other defined response criteria, at the first scheduled tumor assessment (all other cohorts), per RECIST (if assessed) or PERCIST. RECISTv1.1 for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR PERCISTv1.0: Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions. Positive Metabolic Response - Participants having either "Complete Metabolic Response" or "Part
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=36 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=45 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=31 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
n=21 Participants
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
n=26 Participants
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
n=52 Participants
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
n=31 Participants
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
n=25 Participants
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
n=16 Participants
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
n=22 Participants
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
n=38 Participants
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
n=12 Participants
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
n=19 Participants
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
n=7 Participants
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
n=10 Participants
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
n=11 Participants
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
n=7 Participants
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
n=15 Participants
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
n=42 Participants
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
n=16 Participants
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
n=3 Participants
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) at First Assessment by Investigator Review (All Other Cohorts)
|
36.1 percentage of participant
|
42.2 percentage of participant
|
48.4 percentage of participant
|
33.3 percentage of participant
|
3.8 percentage of participant
|
15.4 percentage of participant
|
19.4 percentage of participant
|
12.0 percentage of participant
|
0 percentage of participant
|
13.6 percentage of participant
|
0 percentage of participant
|
0 percentage of participant
|
5.3 percentage of participant
|
0 percentage of participant
|
0 percentage of participant
|
36.4 percentage of participant
|
0 percentage of participant
|
0 percentage of participant
|
4.8 percentage of participant
|
0 percentage of participant
|
0 percentage of participant
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 58 monthsPopulation: Cohort of cancer type and treatment
Percentage of participants who are confirmed by investigator review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer cohorts). Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1) for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),\>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=59 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=7 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=7 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Objective Response Rate (ORR) by Investigator Review (Breast Cancer With Prior CDK46i Cohort)
|
30.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first treatment date to confirmed Complete or Partial Response, assessed up to 58 months.Percentage of participants who achieve CR or PR per RECIST v1.1, or metabolic complete response via PERCIST v1.0. For RECIST, A complete or partial response that is confirmed no less than 4-weeks after the criteria for response are initially met. PERCIST criteria were used for patients without RECIST assessments.
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=36 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=45 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=31 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
n=21 Participants
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
n=26 Participants
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
n=52 Participants
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
n=31 Participants
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
n=25 Participants
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
n=16 Participants
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
n=22 Participants
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
n=38 Participants
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
n=12 Participants
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
n=19 Participants
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
n=7 Participants
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
n=10 Participants
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
n=11 Participants
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
n=7 Participants
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
n=15 Participants
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
n=42 Participants
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
n=16 Participants
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
n=3 Participants
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Confirmed Objective Response Rate (ORR) by Investigator Review (All Other Cohorts)
|
25.0 percentage of participant
|
28.9 percentage of participant
|
35.5 percentage of participant
|
33.3 percentage of participant
|
3.8 percentage of participant
|
9.6 percentage of participant
|
32.3 percentage of participant
|
16.0 percentage of participant
|
0 percentage of participant
|
13.6 percentage of participant
|
2.6 percentage of participant
|
0 percentage of participant
|
5.3 percentage of participant
|
0 percentage of participant
|
0 percentage of participant
|
9.1 percentage of participant
|
0 percentage of participant
|
0 percentage of participant
|
2.4 percentage of participant
|
0 percentage of participant
|
0 percentage of participant
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first response to first disease progression or death, assessed up to 58 monthsPopulation: Number of confirmed responders
Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=24 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=1 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
|
13.14 month
Interval 6.41 to
Upper limits of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
|
—
|
NA month
Median and Upper, lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first response to first disease progression or death, assessed up to 58 monthsPopulation: Number of confirmed responders
Time from which measurement criteria are met for response (whichever status is recorded first) until the first date of documented disease progression or death. Disease progression assessed by RECIST criteria, or for PERCIST for those participants who did not have RECIST performed.
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=23 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
n=9 Participants
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
n=13 Participants
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
n=11 Participants
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
n=7 Participants
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
n=4 Participants
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
n=1 Participants
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
n=5 Participants
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
n=10 Participants
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
n=4 Participants
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
n=3 Participants
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
n=1 Participants
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
n=1 Participants
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
n=1 Participants
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
n=1 Participants
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) by Investigator Review (All Cohorts)
|
14.4 month
Interval 7.8 to 18.6
|
—
|
—
|
4.76 month
Interval 3.71 to 16.62
|
9.23 month
Interval 5.49 to 38.97
|
9.17 month
Interval 4.14 to
Upper limits of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
|
7.28 month
Interval 4.17 to
Upper limits of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
|
7.62 month
Interval 5.55 to 12.25
|
9.23 month
Upper and lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
|
6.80 month
Interval 4.17 to
Upper limits of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
|
22.24 month
Interval 4.01 to 30.03
|
3.75 month
Interval 2.99 to 4.67
|
—
|
7.20 month
Interval 2.76 to 7.59
|
19.94 month
Upper and lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
|
—
|
12.19 month
Upper and lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
|
—
|
—
|
NA month
Median and Upper, lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
|
—
|
—
|
3.71 month
Upper and lower limits of 95% Confidence Interval (CI) were not estimable due to insufficient number of events.
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 monthsPercentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=59 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=7 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=7 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
|
49.2 percentage of participant
|
0 percentage of participant
|
14.3 percentage of participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment date to first documented response or stable disease ≥16, or ≥24 weeks for breast cancer, assessed up to 58 monthsPercentage of participants with CR + PR + stable disease ≥16, or ≥24 weeks for breast cancer, from the date of enrollment.
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=59 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=7 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=7 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
n=36 Participants
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
n=45 Participants
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
n=31 Participants
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
n=21 Participants
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
n=22 Participants
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
n=26 Participants
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
n=52 Participants
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
n=31 Participants
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
n=25 Participants
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
n=16 Participants
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
n=22 Participants
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
n=38 Participants
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
n=12 Participants
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
n=19 Participants
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
n=7 Participants
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
n=10 Participants
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
n=11 Participants
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
n=7 Participants
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
n=15 Participants
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
n=42 Participants
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
n=16 Participants
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
n=3 Participants
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) by Investigator Review (All Cohorts)
|
54.2 percentage of participant
|
0 percentage of participant
|
0 percentage of participant
|
33.3 percentage of participant
|
42.2 percentage of participant
|
54.8 percentage of participant
|
42.9 percentage of participant
|
45.5 percentage of participant
|
38.5 percentage of participant
|
30.8 percentage of participant
|
48.4 percentage of participant
|
24.0 percentage of participant
|
18.8 percentage of participant
|
31.8 percentage of participant
|
10.5 percentage of participant
|
8.3 percentage of participant
|
21.1 percentage of participant
|
14.3 percentage of participant
|
20.0 percentage of participant
|
54.5 percentage of participant
|
0 percentage of participant
|
13.3 percentage of participant
|
19.0 percentage of participant
|
6.3 percentage of participant
|
0 percentage of participant
|
SECONDARY outcome
Timeframe: From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 monthsNumber of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=59 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=7 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=7 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) by Independent Central Review (Breast Cancer With Prior CDK46i Cohort)
|
8.11 month
Interval 6.01 to 16.39
|
2.27 month
Interval 1.61 to
Upper limit of 95% Confidence Interval (CI) was not estimable due to insufficient number of events.
|
4.11 month
Interval 1.87 to 4.11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment date until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to 58 monthsNumber of months between first dose date and the first date on which recurrence, progression, or death due to any cause, is documented, censored at the last tumor assessment or at the initiation of new anticancer therapy. Progression was defined by RECIST criteria for those participants with RECIST assessments; and PERCIST criteria for other participants.
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=59 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=7 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=7 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
n=36 Participants
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
n=45 Participants
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
n=31 Participants
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
n=21 Participants
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
n=22 Participants
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
n=26 Participants
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
n=52 Participants
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
n=31 Participants
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
n=25 Participants
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
n=16 Participants
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
n=22 Participants
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
n=38 Participants
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
n=12 Participants
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
n=19 Participants
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
n=7 Participants
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
n=10 Participants
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
n=11 Participants
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
n=7 Participants
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
n=15 Participants
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
n=42 Participants
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
n=16 Participants
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
n=3 Participants
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) by Investigator Review (All Cohorts)
|
8.3 month
Interval 6.0 to 12.7
|
4.1 month
Interval 1.6 to 4.1
|
3.9 month
Interval 1.9 to 4.1
|
3.48 month
Interval 1.94 to 3.88
|
5.36 month
Interval 3.71 to 9.23
|
8.21 month
Interval 4.07 to 11.01
|
6.24 month
Interval 2.1 to 10.25
|
5.09 month
Interval 1.74 to 7.23
|
4.17 month
Interval 1.87 to 8.8
|
4.01 month
Interval 2.1 to 4.57
|
5.75 month
Interval 2.27 to 9.23
|
2.76 month
Interval 1.05 to 3.75
|
1.77 month
Interval 1.68 to 3.55
|
3.75 month
Interval 1.87 to 5.62
|
1.81 month
Interval 1.02 to 2.69
|
1.71 month
Interval 1.45 to 1.87
|
2.04 month
Interval 1.81 to 3.48
|
1.87 month
Interval 1.61 to 6.87
|
2.37 month
Interval 1.48 to 7.36
|
5.32 month
Interval 1.81 to 9.26
|
1.74 month
Interval 0.82 to 2.23
|
3.58 month
Interval 1.84 to 3.71
|
1.84 month
Interval 1.74 to 2.07
|
1.69 month
Interval 1.41 to 2.04
|
1.71 month
Interval 1.12 to 1.74
|
SECONDARY outcome
Timeframe: From first dose through 28 days after the last dose, assessed up to 75 months.The safety of neratinib in patients as measured by the incidence of treatment-emergent adverse events (TEAE), including serious adverse events (SAEs), in study participants. TEAEs are any adverse event that occurred on or after first dose of investigational product and up to 28 days after the last dose
Outcome measures
| Measure |
Breast HR+ w Prior CDK4/6i (Neratinib + Fulvestrant + Trastuzumab)
n=317 Participants
Consisting of 33 patients from the randomized cohort and 26 from the non-randomized cohort in breast cancer who had prior CDK4/6 inhibitor, treated with (Neratinib + Fulvestrant + Trastuzumab)
|
Breast HR+ w. Prior CDK4/6i (Fulvestrant)
n=45 Participants
Breast HR+ with Prior CDK4/6 inhibitor patients treated with Fulvestrant Monotherapy
|
Breast HR+ With Prior CDK4/6i (Fulvestrant + Trastuzumab)
n=22 Participants
Breast cancer HR+ w prior CDK4/6 inhibitor patients treated with combination of (Fulvestrant + Trastuzumab)
|
Breast Cancer HR- (Neratinib + Trastuzumab)
n=92 Participants
Breast cancer HR- patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer HER2 Mutant (Neratinib)
n=90 Participants
NSCLC Lung cancer HER2 mutant patients treated with Neratinib Monotherapy
|
Lung Cancer HER2 Mutant (Neratinib + Trastuzumab)
n=7 Participants
NSCLC Lung cancer HER2 mutant patients treated with combination of (Neratinib + Trastuzumab)
|
Lung Cancer EGFR Mutant Exon 18 (Neratinib)
n=7 Participants
NSCLC Lung cancer EGFR mutant exon 18 patients treated with Neratinib Monotherapy
|
Biliary Tract Cancer (Neratinib)
Biliary tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib)
Bladder/Urinary Tract cancer patients treated with Neratinib Monotherapy
|
Bladder/Urinary Tract Cancer (Neratinib + Paclitaxel)
Bladder/Urinary Tract cancer patients treated with combination of (Neratinib + Paclitaxel)
|
Brain Cancer (Neratinib)
Primary brain tumors (glioblastoma multiforme (GBM), gliosarcoma, and/or Grade III glioma) patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib)
Colorectal cancer patients treated with Neratinib Monotherapy
|
Colorectal Cancer (Neratinib + Trastuzumab)
Colorectal cancer patients treated with combination of (Neratinib + Trastuzumab)
|
Endometrial Cancer (Neratinib)
Endometrial cancer patients treated with Neratinib Monotherapy
|
Ovarian Cancer (Neratinib)
Ovarian cancer patients treated with Neratinib Monotherapy
|
Salivary Gland Cancer (Neratinib)
Salivary gland cancer patients treated with Neratinib Monotherapy
|
Gastroesophageal Cancer (Neratinib)
Gastroesophageal cancer patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
Fibrolamellar Carcinoma (FLC) (Neratinib)
Fibrolamellar carcinoma (FLC) patients treated with Neratinib Monotherapy
|
HER2 NOS Cancer (Neratinib)
HER2 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER3 NOS Cancer (Neratinib)
HER3 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
HER4 NOS Cancer (Neratinib)
HER4 mutant Solid tumors, not otherwise specified (NOS) patients treated with Neratinib Monotherapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Any treatment-emergent adverse event
|
313 Participants
|
45 Participants
|
21 Participants
|
92 Participants
|
89 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events
Any treatment-emergent serious adverse event
|
144 Participants
|
12 Participants
|
13 Participants
|
45 Participants
|
28 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Neratinib
Serious events: 144 serious events
Other events: 304 other events
Deaths: 231 deaths
Neratinib + Fulvestrant
Serious events: 12 serious events
Other events: 45 other events
Deaths: 31 deaths
Neratinib + Paclitaxel
Serious events: 13 serious events
Other events: 20 other events
Deaths: 14 deaths
Neratinib + Trastuzumab
Serious events: 45 serious events
Other events: 92 other events
Deaths: 71 deaths
Neratinib + Fulvestrant + Trastuzumab
Serious events: 28 serious events
Other events: 89 other events
Deaths: 32 deaths
Fulvestrant
Serious events: 5 serious events
Other events: 7 other events
Deaths: 2 deaths
Fulvestrant + Trastuzumab
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neratinib
n=317 participants at risk
Neratinib Monotherapy (Neratinib 240 mg PO daily)
|
Neratinib + Fulvestrant
n=45 participants at risk
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
|
Neratinib + Paclitaxel
n=22 participants at risk
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
|
Neratinib + Trastuzumab
n=92 participants at risk
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Neratinib + Fulvestrant + Trastuzumab
n=90 participants at risk
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Fulvestrant
n=7 participants at risk
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
|
Fulvestrant + Trastuzumab
n=7 participants at risk
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Eye disorders
Diplopia
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
17/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Ascites
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
30/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
27.3%
6/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.0%
12/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
6/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
42.9%
3/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Ileus
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
9/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
14/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.5%
6/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Asthenia
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Fatigue
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Gait disturbance
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
General physical health deterioration
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Non-cardiac chest pain
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Oedema peripheral
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Pain
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Pyrexia
|
2.2%
7/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Hepatobiliary disorders
Malignant biliary obstruction
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Abdominal infection
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Bacteraemia
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
COVID-19
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Cellulitis
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Clostridium difficile infection
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Cystitis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Device related infection
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Diverticulitis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Gastroenteritis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Herpes zoster
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Infection
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Influenza
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Kidney infection
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Liver abscess
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Perirectal abscess
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Pneumonia
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Pneumonia aspiration
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Sepsis
|
1.9%
6/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Septic shock
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
8/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Vascular device infection
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Blood bilirubin increased
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Blood creatinine increased
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Ejection fraction decreased
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
International normalised ratio increased
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Lymphocyte count decreased
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Neutrophil count decreased
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Troponin I increased
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
10/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Brain oedema
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Coma
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Dizziness
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Dysarthria
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Encephalopathy
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Epilepsy
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Neurological decompensation
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Partial seizures
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Seizure
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Syncope
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Product Issues
Device malfunction
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Agitation
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Confusional state
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Drug abuse
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Mental status changes
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
5/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.2%
4/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.5%
6/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Renal and urinary disorders
Haematuria
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Renal and urinary disorders
Renal failure
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
8/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Surgical and medical procedures
Mammoplasty
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Surgical and medical procedures
Pain management
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Aortic stenosis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Aortic thrombosis
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Embolism
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Hypotension
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
Other adverse events
| Measure |
Neratinib
n=317 participants at risk
Neratinib Monotherapy (Neratinib 240 mg PO daily)
|
Neratinib + Fulvestrant
n=45 participants at risk
Neratinib + Fulvestrant (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Days 1, 15 of the first month, then Day 1 of every 4-week cycle)
|
Neratinib + Paclitaxel
n=22 participants at risk
Neratinib + Paclitaxel (Neratinib 240 mg PO daily + Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 of every 4-week cycle)
|
Neratinib + Trastuzumab
n=92 participants at risk
Neratinib + Trastuzumab (Neratinib 240 mg PO daily + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Neratinib + Fulvestrant + Trastuzumab
n=90 participants at risk
Neratinib + Fulvestrant + Trastuzumab (Neratinib 240 mg PO daily + Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
Fulvestrant
n=7 participants at risk
Fulvestrant (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter)
|
Fulvestrant + Trastuzumab
n=7 participants at risk
Fulvestrant + Trastuzumab (Fulvestrant 500 mg IM on Study Day 1, 15, and 29; once every 28 days thereafter + Trastuzumab 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks)
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.9%
44/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
15.6%
7/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.2%
4/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.5%
17/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.4%
13/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Cardiac disorders
Palpitations
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Eye disorders
Dry eye
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.1%
13/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
10.0%
9/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.9%
60/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
17.8%
8/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
22.7%
5/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.0%
12/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.9%
26/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.6%
5/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
9/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.6%
7/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
8/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Constipation
|
35.0%
111/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
37.8%
17/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
31.8%
7/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
30.4%
28/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
37.8%
34/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.6%
2/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
42.9%
3/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.6%
211/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
86.7%
39/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
72.7%
16/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
80.4%
74/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
91.1%
82/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
85.7%
6/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
85.7%
6/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
16/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
6/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
14/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.7%
8/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
10/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
8/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Flatulence
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.8%
9/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Nausea
|
42.0%
133/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
42.2%
19/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
50.0%
11/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
46.7%
43/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
65.6%
59/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
42.9%
3/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
42.9%
3/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Stomatitis
|
5.0%
16/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.0%
12/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.4%
13/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.1%
105/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
22.2%
10/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
45.5%
10/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
45.7%
42/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
48.9%
44/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.6%
2/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Asthenia
|
8.2%
26/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.2%
4/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
12.0%
11/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.9%
17/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Chills
|
3.2%
10/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.4%
5/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
10.0%
9/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Fatigue
|
30.9%
98/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
26.7%
12/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
45.5%
10/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
35.9%
33/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
36.7%
33/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.6%
2/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Induration
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Injection site pruritus
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Mass
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Oedema peripheral
|
6.6%
21/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
17.8%
8/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.7%
8/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
10/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Pain
|
3.2%
10/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
General disorders
Pyrexia
|
8.5%
27/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
5/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
16.3%
15/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.8%
7/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Immune system disorders
Food allergy
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Infection
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Influenza
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Localised infection
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.8%
7/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Paronychia
|
2.2%
7/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.6%
7/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
8/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Respiratory tract infection
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.5%
8/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
5/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Infections and infestations
Urinary tract infection
|
6.6%
21/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.4%
5/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.3%
12/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Alanine aminotransferase increased
|
8.5%
27/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.5%
6/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Aspartate aminotransferase increased
|
9.8%
31/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
8/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.0%
19/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Blood creatinine increased
|
4.4%
14/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
27.3%
6/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.5%
6/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
10.0%
9/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
6/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Lymphocyte count decreased
|
2.2%
7/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Neutrophil count decreased
|
1.6%
5/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Investigations
Weight decreased
|
10.7%
34/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
5/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
16.3%
15/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
15.6%
14/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.5%
84/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.9%
13/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
27.3%
6/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
27.2%
25/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
37.8%
34/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
42.9%
3/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.3%
20/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.2%
4/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.8%
7/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.8%
9/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.4%
5/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
8/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.2%
7/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.5%
6/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.9%
6/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.4%
5/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.7%
15/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.6%
7/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.3%
12/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.5%
11/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.4%
5/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.8%
7/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
9/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.6%
2/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.5%
11/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.8%
7/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
23/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
15.6%
7/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
22.7%
5/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.0%
12/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
12.2%
11/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.6%
2/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
28/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
17.8%
8/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
12.0%
11/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
7.8%
7/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.63%
2/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.1%
13/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.4%
5/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
16.7%
15/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
8/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.8%
12/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.4%
14/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
5/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.3%
12/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
8/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.3%
6/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.7%
8/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
6/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Dizziness
|
6.6%
21/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.2%
4/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.8%
9/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
6/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Dysgeusia
|
5.7%
18/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.2%
4/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.4%
5/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
10.0%
9/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Headache
|
9.5%
30/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
17.8%
8/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.5%
6/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.9%
17/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.6%
2/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.6%
5/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
22.7%
5/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Nervous system disorders
Paraesthesia
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Anxiety
|
4.1%
13/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Daydreaming
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Depression
|
2.2%
7/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Insomnia
|
3.8%
12/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.3%
6/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.4%
5/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Psychiatric disorders
Mood swings
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Renal and urinary disorders
Pollakiuria
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
2/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Renal and urinary disorders
Renal failure
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
20/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
10.9%
10/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
8/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
24/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
15.6%
7/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.0%
12/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
8/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
9/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.5%
6/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
6/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
8/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
7/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
9.1%
2/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.5%
11/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
12.0%
11/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
5.6%
5/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.3%
20/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
17.8%
8/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
10.0%
9/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.6%
3/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.4%
4/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.32%
1/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
6/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
18/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
4/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
3.3%
3/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
8/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.2%
26/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
15.6%
7/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
18.2%
4/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
13.0%
12/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.4%
13/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.6%
2/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.5%
11/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
5/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.3%
4/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
6/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Haematoma
|
0.00%
0/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
1/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Hot flush
|
1.3%
4/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
5/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.9%
8/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Hypertension
|
6.0%
19/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
4.5%
1/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
8.7%
8/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
11.1%
10/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
28.6%
2/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
|
Vascular disorders
Lymphoedema
|
0.95%
3/317 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
6.7%
3/45 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/22 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
2.2%
2/92 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
1.1%
1/90 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
14.3%
1/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
0.00%
0/7 • All events from day 1 of study drug through 28 days after last dose are included, up to 75 months.
|
Additional Information
Sr Director, Clinical Operations
Puma Biotechnology, Inc.
Phone: 4242486500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place