Trial Outcomes & Findings for CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (NCT NCT03568422)
NCT ID: NCT03568422
Last Updated: 2025-03-25
Results Overview
The maximum tolerated dose of CFI-402257 for phase II study identified by a standard 3+3 design to escalate the dose of CFI-402257.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
During cycle 1 (28 days)
Results posted on
2025-03-25
Participant Flow
There were five dose levels in the phase I component of this study with respectively 4, 3, 6, 7, and 6 patients enrolled. Based on the results from patients on dose levels 4 and 5, dose level 3 was expanded with 11 additional patients enrolled. From the results of a total of 17 patients enrolled in this dose level, dose level 3 was declared as the recommended phase II dose and all 17 patients enrolled in dose level 3 were considered to be Phase II patients for the analyses.
Participant milestones
| Measure |
Phase I: Dose Level 1 (CFI-402257 84 mg + Paclitaxel 80 mg/m2)
Oral CFI-402257 84 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase 1: Dose Level 2 (CFI-402257 112 mg + Paclitaxel 80 mg/m2)
Oral CFI-402257 112 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase 1: Dose Level 3 (CFI-402257 168 mg + Paclitaxel 80 mg/m2)
Oral CFI-402257 168 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I: Dose Level 4 (CFI-402257 210 mg + Paclitaxel 80 mg/m2))
Oral CFI-402257 210 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I: Dose Level 5 (CFI-402257 252 mg + Paclitaxel 80 mg/m2)
Oral CFI-402257 252 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Expansion Cohort: CFI-402257 168 mg + Paclitaxel 80 mg/m2
Oral CFI-402257 168 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
6
|
7
|
6
|
11
|
|
Overall Study
COMPLETED
|
4
|
3
|
6
|
7
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Level 1 (CFI-402257 84 mg + Paclitaxel 80 mg/m2)
n=4 Participants
Oral CFI-402257 84 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 2 (CFI-402257 112 mg + Paclitaxel 80 mg/m2)
n=3 Participants
Oral CFI-402257 112 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 3 and Expansion Cohort (CFI-402257 168 mg + Paclitaxel 80 mg/m2)
n=17 Participants
Oral CFI-402257 168 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 4 (CFI-402257 210 mg + Paclitaxel 80 mg/m2))
n=7 Participants
Oral CFI-402257 210 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 5 (CFI-402257 252 mg + Paclitaxel 80 mg/m2)
n=6 Participants
Oral CFI-402257 252 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
48 years
n=7 Participants
|
58 years
n=5 Participants
|
62 years
n=4 Participants
|
65 years
n=21 Participants
|
59 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
17 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
37 participants
n=8 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
0
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
ECOG (Eastern Cooperative Oncology Group) Performance Status
1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: During cycle 1 (28 days)Population: There were five dose levels in the phase I component of this study with respectively 4, 3, 6, 7, and 6 patients enrolled. Based on the results, dose level 3 was declared as the recommended phase II dose.
The maximum tolerated dose of CFI-402257 for phase II study identified by a standard 3+3 design to escalate the dose of CFI-402257.
Outcome measures
| Measure |
CFI-402257 + Paclitaxel
n=26 Participants
Oral CFI-402257 at 5 dose levels on intermittent schedule:
days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
|---|---|
|
Phase I: Recommended Phase II Dose for CFI-402257
|
168 mg
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants who received Dose Level 3 in Phase I and in the expansion cohort are combined for analysis of this outcome measure.
Percentage of patients with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
CFI-402257 + Paclitaxel
n=17 Participants
Oral CFI-402257 at 5 dose levels on intermittent schedule:
days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
|---|---|
|
Phase II: Overall Response Rate Using RECIST 1.1
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants who received Dose Level 3 in Phase I and in the expansion cohort are combined for analysis of this outcome measure.
Percentage of patients with a complete response (CR) or partial response (PR), or with stable disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), \<30% decrease in the sum of the longest diameter of target lesions but \<20% increase in the sum of the longest diameter of target lesions\>16 weeks of duration; Overall clinical benefit = CR + PR+SD.
Outcome measures
| Measure |
CFI-402257 + Paclitaxel
n=17 Participants
Oral CFI-402257 at 5 dose levels on intermittent schedule:
days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
|---|---|
|
Phase II: Clinical Benefit Rate Determined by Complete Response, Partial Response or Stable Disease
|
8 Participants
|
Adverse Events
Phase I Dose Level 1 (CFI-402257 84 mg + Paclitaxel 80 mg/m2)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase I Dose Level 2 (CFI-402257 112 mg + Paclitaxel 80 mg/m2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I Dose Level 3 and Expansion Cohort (CFI-402257 168 mg + Paclitaxel 80 mg/m2)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 16 deaths
Phase I Dose Level 4 (CFI-402257 210 mg + Paclitaxel 80 mg/m2))
Serious events: 2 serious events
Other events: 7 other events
Deaths: 5 deaths
Phase I Dose Level 5 (CFI-402257 252 mg + Paclitaxel 80 mg/m2)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Phase I Dose Level 1 (CFI-402257 84 mg + Paclitaxel 80 mg/m2)
n=4 participants at risk
Oral CFI-402257 84 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 2 (CFI-402257 112 mg + Paclitaxel 80 mg/m2)
n=3 participants at risk
Oral CFI-402257 112 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 3 and Expansion Cohort (CFI-402257 168 mg + Paclitaxel 80 mg/m2)
n=17 participants at risk
Oral CFI-402257 168 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 4 (CFI-402257 210 mg + Paclitaxel 80 mg/m2))
n=7 participants at risk
Oral CFI-402257 210 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 5 (CFI-402257 252 mg + Paclitaxel 80 mg/m2)
n=6 participants at risk
Oral CFI-402257 252 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
|---|---|---|---|---|---|
|
Infections and infestations
Catheter related infection
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Fever
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Metabolism and nutrition disorders
Other metabolism and nutrition disorders
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
Other adverse events
| Measure |
Phase I Dose Level 1 (CFI-402257 84 mg + Paclitaxel 80 mg/m2)
n=4 participants at risk
Oral CFI-402257 84 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 2 (CFI-402257 112 mg + Paclitaxel 80 mg/m2)
n=3 participants at risk
Oral CFI-402257 112 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 3 and Expansion Cohort (CFI-402257 168 mg + Paclitaxel 80 mg/m2)
n=17 participants at risk
Oral CFI-402257 168 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 4 (CFI-402257 210 mg + Paclitaxel 80 mg/m2))
n=7 participants at risk
Oral CFI-402257 210 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
Phase I Dose Level 5 (CFI-402257 252 mg + Paclitaxel 80 mg/m2)
n=6 participants at risk
Oral CFI-402257 252 mg on intermittent schedule: days 1, 2, 8, 9, 15 \& 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 \& 15 every 28 days
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • 2 years
|
33.3%
1/3 • 2 years
|
35.3%
6/17 • 2 years
|
14.3%
1/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • 2 years
|
33.3%
1/3 • 2 years
|
70.6%
12/17 • 2 years
|
42.9%
3/7 • 2 years
|
33.3%
2/6 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • 2 years
|
33.3%
1/3 • 2 years
|
58.8%
10/17 • 2 years
|
57.1%
4/7 • 2 years
|
33.3%
2/6 • 2 years
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • 2 years
|
33.3%
1/3 • 2 years
|
47.1%
8/17 • 2 years
|
14.3%
1/7 • 2 years
|
33.3%
2/6 • 2 years
|
|
General disorders
Fatigue
|
100.0%
4/4 • 2 years
|
33.3%
1/3 • 2 years
|
76.5%
13/17 • 2 years
|
85.7%
6/7 • 2 years
|
100.0%
6/6 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
50.0%
2/4 • 2 years
|
33.3%
1/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • 2 years
|
0.00%
0/3 • 2 years
|
29.4%
5/17 • 2 years
|
14.3%
1/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • 2 years
|
66.7%
2/3 • 2 years
|
52.9%
9/17 • 2 years
|
71.4%
5/7 • 2 years
|
33.3%
2/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
2/4 • 2 years
|
0.00%
0/3 • 2 years
|
17.6%
3/17 • 2 years
|
42.9%
3/7 • 2 years
|
50.0%
3/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
50.0%
2/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
23.5%
4/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
2/4 • 2 years
|
33.3%
1/3 • 2 years
|
41.2%
7/17 • 2 years
|
57.1%
4/7 • 2 years
|
33.3%
2/6 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 2 years
|
100.0%
3/3 • 2 years
|
35.3%
6/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Paresthesia
|
50.0%
2/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
42.9%
3/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
75.0%
3/4 • 2 years
|
66.7%
2/3 • 2 years
|
58.8%
10/17 • 2 years
|
42.9%
3/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
28.6%
2/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
35.3%
6/17 • 2 years
|
71.4%
5/7 • 2 years
|
50.0%
3/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
52.9%
9/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Eye disorders
Cataract
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Eye disorders
Other eye disorders - Double vision
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • 2 years
|
66.7%
2/3 • 2 years
|
70.6%
12/17 • 2 years
|
28.6%
2/7 • 2 years
|
33.3%
2/6 • 2 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
33.3%
2/6 • 2 years
|
|
Hepatobiliary disorders
Hepatic pain
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Bronchial infection
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Nail infection
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Infections and infestations
Other infections and infestations - Common cold
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • 2 years
|
33.3%
1/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Dysarthria
|
25.0%
1/4 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Movements involuntary
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Nystagmus
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • 2 years
|
66.7%
2/3 • 2 years
|
35.3%
6/17 • 2 years
|
28.6%
2/7 • 2 years
|
33.3%
2/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
50.0%
2/4 • 2 years
|
33.3%
1/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
4/4 • 2 years
|
66.7%
2/3 • 2 years
|
76.5%
13/17 • 2 years
|
42.9%
3/7 • 2 years
|
66.7%
4/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
50.0%
2/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders - Thinning of eyebrows and eyelashes, and Erythematous
|
50.0%
2/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Vascular disorders
Flushing
|
50.0%
2/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Vascular disorders
Lymphedema
|
25.0%
1/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Chills
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Edema limbs
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
11.8%
2/17 • 2 years
|
14.3%
1/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
General disorders
Fever
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
11.8%
2/17 • 2 years
|
14.3%
1/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 2 years
|
66.7%
2/3 • 2 years
|
23.5%
4/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
11.8%
2/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • 2 years
|
66.7%
2/3 • 2 years
|
29.4%
5/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Surgical and medical procedures
Other surgical and medical procedures - Back pain due to biopsy
|
0.00%
0/4 • 2 years
|
33.3%
1/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Eye disorders
Flashing lights
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Eye disorders
Other eye disorders - Stye
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
17.6%
3/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
17.6%
3/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Edema face
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Pain
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Other general disorders, administration site conditions - Pain to site of PleurX
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Shingles
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Other infections and infestations - COVID-19 infection
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
42.9%
3/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
42.9%
3/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal and connective tissue disorder - Port site pain
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasms benign, malignant and unspecified - Lump on right neck
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Anosmia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
28.6%
2/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Renal and urinary disorders
Other renal and urinary disorders - Intermittent delay in starting urination
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders - Hemoptysis
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
11.8%
2/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders - Erythema around Port-a-Cath, Skin discolouration, and
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
17.6%
3/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Vascular disorders
Other vascular disorders - Small non-occlusive thrombosis in bilateral gonadal veins
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
5.9%
1/17 • 2 years
|
0.00%
0/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Infections and infestations
Other infections and infestations - Influenza
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
0.00%
0/6 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
14.3%
1/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Reproductive system and breast disorders
Vaginismus
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/4 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/17 • 2 years
|
0.00%
0/7 • 2 years
|
16.7%
1/6 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place