Trial Outcomes & Findings for Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer (NCT NCT01827267)
NCT ID: NCT01827267
Last Updated: 2018-07-03
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
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.
Results posted on
2018-07-03
Participant Flow
Participant milestones
| Measure |
Neratinib
Neratinib 240 mg
|
Neratinib+Temsirolimus
Neratinib 240 mg + Temsirolimus 15 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
44
|
|
Overall Study
Received Study Drug
|
17
|
43
|
|
Overall Study
Crossed Over to Neratinib + Temsirolimus
|
11
|
0
|
|
Overall Study
COMPLETED
|
13
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
12
|
Reasons for withdrawal
| Measure |
Neratinib
Neratinib 240 mg
|
Neratinib+Temsirolimus
Neratinib 240 mg + Temsirolimus 15 mg.
|
|---|---|---|
|
Overall Study
Did not receive study drug
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Disease Progression
|
1
|
1
|
|
Overall Study
Sponsor Discontinued Study
|
2
|
8
|
|
Overall Study
Still on study
|
0
|
2
|
Baseline Characteristics
Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Neratinib
n=17 Participants
Neratinib 240 mg
|
Neratinib+Temsirolimus
n=43 Participants
Neratinib 240 mg + Temsirolimus 15 mg.
|
Total
n=60 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
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
62.24 years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
63.44 years
STANDARD_DEVIATION 12.72 • n=7 Participants
|
63.10 years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.Population: All subjects who received at least 1 dose of drug
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 |
Neratinib
n=17 Participants
Neratinib 240 mg
|
Neratinib+Temsirolimus
n=43 Participants
Neratinib 240 mg + Temsirolimus 15 mg.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.Population: All subjects who received at least one dose.
CBR is defined as the proportion of patients who achieved objective response (CR or PR) or stable disease (SD) for at least 12 weeks.
Outcome measures
| Measure |
Neratinib
n=17 Participants
Neratinib 240 mg
|
Neratinib+Temsirolimus
n=43 Participants
Neratinib 240 mg + Temsirolimus 15 mg.
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
6 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.Population: All subjects who received at least 1 dose of drug and had either complete or partial response.
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 RECIST (v1.1) criteria.
Outcome measures
| Measure |
Neratinib
Neratinib 240 mg
|
Neratinib+Temsirolimus
n=6 Participants
Neratinib 240 mg + Temsirolimus 15 mg.
|
|---|---|---|
|
Duration of Response (DOR)
Less than 3 months
|
0 Participants
|
2 Participants
|
|
Duration of Response (DOR)
3 to less than 6 months
|
0 Participants
|
2 Participants
|
|
Duration of Response (DOR)
6 to less than 12 months
|
0 Participants
|
0 Participants
|
|
Duration of Response (DOR)
Greater than 12 months
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.Population: All subjects who received at least 1 dose of drug
Defined as time from date of randomization until the first disease recurrence or progression per RECIST V1.1 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 |
Neratinib
n=17 Participants
Neratinib 240 mg
|
Neratinib+Temsirolimus
n=43 Participants
Neratinib 240 mg + Temsirolimus 15 mg.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
2.9 months
Interval 1.4 to 9.8
|
4.0 months
Interval 2.9 to 5.4
|
SECONDARY outcome
Timeframe: From randomization to death or end of long term follow-up, assessed up to 31.8 months.Population: All subjects who received at least 1 dose of drug
Defined as the time (month) from randomization to death due to any cause; censored at the date last known alive.
Outcome measures
| Measure |
Neratinib
n=17 Participants
Neratinib 240 mg
|
Neratinib+Temsirolimus
n=43 Participants
Neratinib 240 mg + Temsirolimus 15 mg.
|
|---|---|---|
|
Overall Survival (OS)
|
10.0 months
Interval 4.9 to 18.9
|
15.1 months
Interval 10.8 to 17.7
|
Adverse Events
Neratinib
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Neratinib+Temsirolimus
Serious events: 16 serious events
Other events: 43 other events
Deaths: 0 deaths
Ner+Tem Post Crossover
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neratinib
n=17 participants at risk
Neratinib 240 mg
|
Neratinib+Temsirolimus
n=43 participants at risk
Neratinib 240 mg + Temsirolimus 15 mg.
|
Ner+Tem Post Crossover
n=11 participants at risk
Neratinib 240 mg + Temsirolimus 15 mg for subjects who crossed over from Neratinb 240 mg arm
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
General physical health deterioration
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.2%
2/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Infection
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Blood uric acid increased
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
General physical condition abnormal
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Nervous system disorder
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Pachymeningitis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Renal and urinary disorders
Urinary retention
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.2%
2/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Vascular disorders
Embolism
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
Other adverse events
| Measure |
Neratinib
n=17 participants at risk
Neratinib 240 mg
|
Neratinib+Temsirolimus
n=43 participants at risk
Neratinib 240 mg + Temsirolimus 15 mg.
|
Ner+Tem Post Crossover
n=11 participants at risk
Neratinib 240 mg + Temsirolimus 15 mg for subjects who crossed over from Neratinb 240 mg arm
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
29.4%
5/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
41.9%
18/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
45.5%
5/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Cardiac disorders
Arrhythmia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Cardiac disorders
Left atrial dilatation
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Cardiac disorders
Tachycardia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Eye disorders
Vision blurred
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
35.3%
6/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.6%
8/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
17.6%
3/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Cheilosis
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Constipation
|
41.2%
7/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
41.9%
18/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
76.5%
13/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
86.0%
37/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
45.5%
5/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Nausea
|
41.2%
7/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
55.8%
24/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
48.8%
21/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.2%
2/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
32.6%
14/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Asthenia
|
35.3%
6/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
27.9%
12/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Catheter site erythema
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Catheter site related reaction
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Chest discomfort
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Chills
|
17.6%
3/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
11.6%
5/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Fatigue
|
23.5%
4/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
39.5%
17/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Gait disturbance
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Influenza like illness
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Local swelling
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Malaise
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Nodule
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Non-cardiac chest pain
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Oedema
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
16.3%
7/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Pain
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
General disorders
Pyrexia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.2%
2/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Cystitis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Endocarditis
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Escherichia urinary tract infection
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Herpes zoster
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Lung infection
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Paronychia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Pyelonephritis
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Infections and infestations
Urinary tract infection
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Injury, poisoning and procedural complications
Fracture
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
23.3%
10/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Amylase increased
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
23.3%
10/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Blood calcium decreased
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Blood creatinine increased
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Blood lactate dehydrogenase increased
|
17.6%
3/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
11.6%
5/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
International normalised ratio increased
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Prothrombin time prolonged
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
Weight decreased
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
23.3%
10/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
White blood cell count decreased
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
11.6%
5/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Investigations
White blood cell count increased
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.5%
4/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
53.5%
23/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.2%
2/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
14.0%
6/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
16.3%
7/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.2%
2/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
30.2%
13/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
11.6%
5/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.2%
2/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
11.6%
5/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.6%
8/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Dysaesthesia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
30.2%
13/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
23.3%
10/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Nervous system disorders
Somnolence
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
7.0%
3/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
18.2%
2/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
16.3%
7/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Renal and urinary disorders
Dysuria
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
14.0%
6/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Renal and urinary disorders
Nocturia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Renal and urinary disorders
Renal failure
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Renal and urinary disorders
Renal failure acute
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
23.3%
10/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.4%
5/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
32.6%
14/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
2/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
27.9%
12/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
11.6%
5/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
23.3%
10/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
11.6%
5/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
2.3%
1/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
4.7%
2/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.3%
4/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.5%
4/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
27.9%
12/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
11.6%
5/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
5.9%
1/17 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
0.00%
0/43 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
9.1%
1/11 • From time of first dose through 28 days after last dose, assessed up to 116.5 weeks.
|
Additional Information
Senior Director, Clinical Operations
Puma Biotechnology
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