Trial Outcomes & Findings for Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer (NCT NCT05493501)
NCT ID: NCT05493501
Last Updated: 2024-05-02
Results Overview
PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
8 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2024-05-02
Participant Flow
Participant milestones
| Measure |
Aumolertinib Monotherapy
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
|
Aumolertinib + Platinum-based Doublet Chemotherapy
For adenocarcinoma, either:
* Aumolertinib + cisplatin with pemetrexed, or
* Aumolertinib + carboplatin with pemetrexed
For squamous cell carcinoma, one of the following:
* Aumolertinib + cisplatin or carboplatin with paclitaxel;
* Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or
* Aumolertinib + cisplatin or carboplatin with gemcitabine
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy
Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information.
Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information.
Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.
|
Osimertinib Monotherapy
Osimertinib monotherapy: 80 mg tablet administered orally, once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Aumolertinib Monotherapy
n=1 Participants
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
|
Aumolertinib + Platinum-based Doublet Chemotherapy
n=2 Participants
For adenocarcinoma, either:
* Aumolertinib + cisplatin with pemetrexed, or
* Aumolertinib + carboplatin with pemetrexed
For squamous cell carcinoma, one of the following:
* Aumolertinib + cisplatin or carboplatin with paclitaxel;
* Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or
* Aumolertinib + cisplatin or carboplatin with gemcitabine
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy
Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information.
Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information.
Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.
|
Osimertinib Monotherapy
n=5 Participants
Osimertinib monotherapy: 80 mg tablet administered orally, once daily
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
71 years
n=107 Participants
|
63 years
n=206 Participants
|
66 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: data not collected, 0 participants analyzed
OS is defined as the time from date of randomization until death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
ORR is defined as proportion of participants who achieve a complete response or partial response at any time before progressive disease or initiating a subsequent anticancer therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
DOR is defined as date of first response (complete response or partial response) until date of disease progression or death due to any cause, whichever occurs first
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
ORR is defined as the proportion of participants who achieve a complete response or partial response at any time before disease progression or initiating a subsequent anticancer therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
TGR is defined as the constant exponential growth rate estimated using the sum of longest diameters based on radiological tumor assessment per RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
DOR is defined as date of first response (complete response or partial response) until the date of disease progression or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: data not collected, 0 participants analyzed
NCI PRO-CTCAE questionnaire responses are scored from 0 to 4, wherein lower values represent a better outcome. For this trial, the burden of symptoms that will be captured by this questionnaire comprises nausea, diarrhea, and rash.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: data not collected, 0 participants analyzed
ctDNA clearance is defined as when a detectable EGFR mutation in ctDNA at baseline becomes undetectable or drops below a predetermined threshold. Rate of ctDNA clearance is defined as 100 × number of participants who are ctDNA-negative at 6 weeks divided by number of participants who are ctDNA-positive at baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 5 monthsPopulation: data not collected, 0 participants analyzed
Plasma concentration is defined as the measured drug concentration of aumolertinib.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 5 monthsPopulation: data not collected, 0 participants analyzed
Plasma concentration is defined as the measured drug concentration of aumolertinib metabolite.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 yearsPopulation: data not collected, 0 participants analyzed
This outcome will evaluate the incidence of participants with TEAEs, graded according to NCI CTCAE V5.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 yearsPopulation: data not collected, 0 participants analyzed
This outcome will evaluate incidence of participants with SAEs, be graded according to NCI CTCAE V5.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 yearsPopulation: data not collected, 0 participants analyzed
This outcome will evaluate incidence of participants with ECG abnormalities
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), up to 5 yearsPopulation: data not collected, 0 participants analyzed
This outcome will evaluate incidence of participants with laboratory abnormalities, graded according to NCI CTCAE V5.
Outcome measures
Outcome data not reported
Adverse Events
Aumolertinib Monotherapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Aumolertinib + Platinum-based Doublet Chemotherapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Osimertinib Monotherapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aumolertinib Monotherapy
n=1 participants at risk
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
|
Aumolertinib + Platinum-based Doublet Chemotherapy
n=2 participants at risk
For adenocarcinoma, either:
* Aumolertinib + cisplatin with pemetrexed, or
* Aumolertinib + carboplatin with pemetrexed
For squamous cell carcinoma, one of the following:
* Aumolertinib + cisplatin or carboplatin with paclitaxel;
* Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or
* Aumolertinib + cisplatin or carboplatin with gemcitabine
Aumolertinib monotherapy: Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
Pemetrexed: Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy
Cisplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
Carboplatin: Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
Paclitaxel: Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information.
Nab paclitaxel: Administered by IV Infusion given over 4 fixed cycles per prescribing information.
Gemcitabine: Administered by IV Infusion over 4 fixed cycles per prescribing information.
|
Osimertinib Monotherapy
n=5 participants at risk
Osimertinib monotherapy: 80 mg tablet administered orally, once daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
100.0%
2/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
60.0%
3/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
50.0%
1/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
100.0%
2/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
50.0%
1/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
100.0%
2/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
50.0%
1/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
50.0%
1/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
50.0%
1/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
100.0%
1/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
20.0%
1/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
40.0%
2/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
50.0%
1/2 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
0.00%
0/5 • Adverse events were collected until the study reached early termination. Adverse events were collected from date of treatment initiation until discontinuation from treatment (plus 28 days for TEAEs), approximately 8 months, 17 days.
The trial was discontinued at 8 months. No patients were analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place