Trial Outcomes & Findings for Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer (NCT NCT01111825)
NCT ID: NCT01111825
Last Updated: 2018-09-26
Results Overview
ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: 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. A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
99 participants
Primary outcome timeframe
From enrollment date to first documented response, or last tumor assessment, assessed up to two years
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
Phase 1
Phase I, HER - Amplified (HER2-Positive) cohort
|
Phase 2 Triple -ve
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
37
|
48
|
|
Overall Study
COMPLETED
|
5
|
5
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
8
|
21
|
Reasons for withdrawal
| Measure |
Phase 1
Phase I, HER - Amplified (HER2-Positive) cohort
|
Phase 2 Triple -ve
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
4
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
0
|
0
|
|
Overall Study
Discontinuation by Sponsor
|
0
|
0
|
0
|
20
|
Baseline Characteristics
Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Phase 1
n=8 Participants
Phase I, HER - Amplified (HER2-Positive) cohort
|
Phase 2 Triple -ve
n=6 Participants
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
n=37 Participants
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
n=48 Participants
Phase 2, HER2 - Positive cohort with dose escalation
|
Total
n=99 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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
85 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
52.3 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From enrollment date to first documented response, or last tumor assessment, assessed up to two yearsPopulation: Intent to Treat (ITT) population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.
ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: 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. A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met.
Outcome measures
| Measure |
Phase 2 Triple -ve
n=6 Participants
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
n=37 Participants
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
n=48 Participants
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|
|
Objective Response Rate (ORR) (Phase II)
|
0 Participants
|
5 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From enrollment date to first documented response, or last tumor assessment, assessed up to two yearsPopulation: ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.
Defined as the proportion of patients who achieved objective response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: 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), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Clinical Benefit (CB) = CR + PR + SD \>= 24 weeks.
Outcome measures
| Measure |
Phase 2 Triple -ve
n=6 Participants
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
n=37 Participants
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
n=48 Participants
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
0 Participants
|
8 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From first response to first PD or death, assessed up to two years.Population: Patients who were enrolled and responded in the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis. Note, no subject in Phase II triple negative cohort had a response. Therefore, no participants were analyzed for DOR.
Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, Progressive Disease (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: 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; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and/or the appearance of one or more new lesions.
Outcome measures
| Measure |
Phase 2 Triple -ve
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
n=5 Participants
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
n=14 Participants
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|
|
Duration of Response (DOR)
0 to <3 months
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Duration of Response (DOR)
3 to <6 months
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Duration of Response (DOR)
6 to <9 months
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Duration of Response (DOR)
9 to <12 months
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Duration of Response (DOR)
12+ months
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From date of enrollment until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to two years.Population: ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.
Defined as time from date of enrollment until the first disease recurrence or progression or death due to any cause; censored at the last assessable evaluation or at the initiation of new anti-cancer therapy. Disease assessment is based on investigator tumor assessments. If no post-baseline tumor assessment then censored at enrollment date.
Outcome measures
| Measure |
Phase 2 Triple -ve
n=6 Participants
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
n=37 Participants
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
n=48 Participants
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.8 months
Interval 1.8 to 2.0
|
4.8 months
Interval 2.7 to 8.4
|
6.0 months
Interval 3.7 to 8.3
|
SECONDARY outcome
Timeframe: From enrollment to date of death from any cause, or end of long term follow-up, assessed up to three years.Population: ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.
Defined as the time from enrollment to death due to any cause; censored at the date last known alive.
Outcome measures
| Measure |
Phase 2 Triple -ve
n=48 Participants
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|
|
Overall Survival (OS)
|
17.8 months
Interval 13.4 to
Upper limit of confidence interval is not estimable.
|
—
|
—
|
Adverse Events
Phase 1
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 2 Triple -ve
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 HER2+
Serious events: 12 serious events
Other events: 37 other events
Deaths: 0 deaths
Phase 2 HER2+ Dose Esc
Serious events: 20 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1
n=8 participants at risk
Phase I, HER - Amplified (HER2-Positive) cohort
|
Phase 2 Triple -ve
n=6 participants at risk
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
n=37 participants at risk
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
n=48 participants at risk
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Eye disorders
Eyelid oedema
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Chest pain
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Empyema
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Haemoglobin increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Cerebral disorder
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Spinal cord compression
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
33.3%
2/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
Other adverse events
| Measure |
Phase 1
n=8 participants at risk
Phase I, HER - Amplified (HER2-Positive) cohort
|
Phase 2 Triple -ve
n=6 participants at risk
Phase 2, Triple - Negative cohort
|
Phase 2 HER2+
n=37 participants at risk
Phase 2, HER2 - Amplified (HER2-Positive) cohort
|
Phase 2 HER2+ Dose Esc
n=48 participants at risk
Phase 2, HER2 - Positive cohort with dose escalation
|
|---|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Fatigue
|
75.0%
6/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
50.0%
3/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
54.1%
20/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
18.8%
9/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Oedema peripheral
|
25.0%
2/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
18.8%
9/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
18.8%
9/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
83.3%
5/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
48.6%
18/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
41.7%
20/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Stomatitis
|
62.5%
5/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
66.7%
4/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
67.6%
25/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
60.4%
29/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
50.0%
3/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
24.3%
9/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
47.9%
23/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Asthenia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
37.5%
18/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Chest pain
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
33.3%
2/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
18.9%
7/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
43.8%
21/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
87.5%
7/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
83.3%
5/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
94.6%
35/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
83.3%
40/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
12.5%
6/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Dyspepsia
|
37.5%
3/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Glossodynia
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
20.8%
10/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Eye disorders
Vision blurred
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
13.5%
5/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
8/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Pain
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
General disorders
Pyrexia
|
25.0%
2/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.2%
6/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Immune system disorders
Hypersensitivity
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Localised infection
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.4%
5/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Onychomycosis
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Paronychia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.8%
4/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Injury, poisoning and procedural complications
Stoma site ulcer
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Monocyte count increased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Weight decreased
|
37.5%
3/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
33.3%
2/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
13.5%
5/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
12.5%
6/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Investigations
Weight increased
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
4/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.2%
6/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
39.6%
19/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
4/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
50.0%
3/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.2%
6/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.4%
5/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
33.3%
2/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.2%
6/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
2/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
12.5%
6/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.2%
6/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.8%
4/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
33.3%
2/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
22.9%
11/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Migraine
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Neuralgia
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
2/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
18.9%
7/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
13.5%
5/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Reproductive system and breast disorders
Breast pain
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
33.3%
2/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.8%
4/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
18.8%
9/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
6.2%
3/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
50.0%
3/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
18.8%
9/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.1%
3/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
20.8%
10/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.4%
5/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
25.0%
2/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
50.0%
3/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.8%
4/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
4/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
33.3%
2/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
18.9%
7/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
8.3%
4/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
5.4%
2/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.4%
5/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
33.3%
2/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
10.8%
4/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
14.6%
7/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
45.9%
17/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
43.8%
21/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
16.7%
1/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Vascular disorders
Hot flush
|
25.0%
2/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.1%
1/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Vascular disorders
Lymphoedema
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
2.7%
1/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
4.2%
2/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
|
Vascular disorders
Post thrombotic syndrome
|
12.5%
1/8 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/6 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/37 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
0.00%
0/48 • From first dose through 28 days after last dose, assessed up to two years.
Safety Population
|
Additional Information
Senior Director, Clinical Operations
Puma Biotechnology, Inc.
Phone: +1 (424) 248-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60